Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency

A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency

Sponsors

Lead Sponsor: American Regent, Inc.

Collaborator: Duke Clinical Research Institute

Source American Regent, Inc.
Brief Summary

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

Detailed Description

This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) distance for patients in heart failure with iron deficiency. After an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment. Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. In a subset of sites, a sub-study will be conducted to characterize serum phosphate levels over time in participants with heart failure and iron deficiency after dosing with FCM. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.

Overall Status Recruiting
Start Date 2017-03-15
Completion Date 2023-06-01
Primary Completion Date 2021-12-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of death 1 year
Incidence of hospitalization for heart failure 1 year
Change in 6MWT distance 6 months
Enrollment 3014
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ferric Carboxymaltose

Description: Intravenous Iron

Arm Group Label: Ferric Carboxymaltose

Other Name: Injectafer, Ferinject

Intervention Type: Drug

Intervention Name: Placebo

Description: Normal Saline Solution

Arm Group Label: Placebo

Other Name: Saline solution

Eligibility

Criteria:

Inclusion Criteria: 1. Adult (≥18 years of age) able to provide signed, written informed consent. 2. Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 2 weeks prior to randomization. 3. Able and willing to perform a 6MWT at the time of randomization. 4. Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical intervention including coronary artery bypass graft (CABG), valvular repair/replacement, or cardiac resynchronization therapy (CRT) device implantation. a. Left ventricular ejection fraction ≤ 40% obtained during the screening visit OR either of the following i. Historical value of ejection fraction ≤ 40% within 24 months of screening visit ii. Historical value of ejection fraction ≤ 30% within 36 months of screening visit 5. Hemoglobin >9.0 g/dL and < 13.5 g/dL (females) or <15.0 g/dL (males) within 28 days of randomization. 6. Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.Patients with screening ferritin <15 ng/mL must have documentation of an appropriate evaluation, as determined by the Principle Investigator, within 3 months of screening and prior to randomization. 7. Either documented hospitalization for heart failure within 12 months of enrollment or elavated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization. a. For patients in normal sinus rhythm: N-terminal-pro-brain natriuretic peptide (NT- proBNP) > 600 pg/mL (or BNP >200 pg/mL) . b . For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL) . Exclusion Criteria: 1. Known hypersensitivity reaction to any component of FCM. 2. History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion. 3. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment. 4. Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention. 5. Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest). 6. Current or planned mechanical circulatory support or heart transplantation. 7. Hemodialysis or peritoneal dialysis (current or planned within the next 6 months). 8. Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range). 9. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia. 10. Active gastrointestinal bleeding. 11. Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication. 12. Inability to return for follow up visits within the necessary windows 13. Concurrently in a study with investigational product. 14. No participants with Current COVID-19 Infection into the study.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Adrian F Hernandez, MD Study Chair Duke Clinical Research Institute
Overall Contact

Last Name: James Bambrick

Phone: 631-379-8831

Phone Ext.: 61818

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Advanced Cardiovascular LLC | Alexander City, Alabama, 35010, United States Recruiting Sabrina Forbus, RN BSN 256-215-5323 [email protected] William R Davis, MD Principal Investigator
Advanced Cardiovascular, LLC | Auburn, Alabama, 36830, United States Recruiting Sabrina Forbus, RN BSN 334-290-2550 [email protected] Brian Foley, MD Principal Investigator
IMC/Diagnostic & Medical Clinic | Mobile, Alabama, 36604, United States Recruiting Patricia Sullivan 251-435-1210 [email protected] Frank M Lester, MD Principal Investigator
University of South Alabama | Mobile, Alabama, 36617, United States Recruiting Cherie Revere, CRNP 251-471-7027 [email protected] Christopher Malozzi, DO Principal Investigator
Alaska Heart & Vascular Institute | Anchorage, Alaska, 99508, United States Active, not recruiting
Verde Valley Medical Center | Cottonwood, Arizona, 86326, United States Active, not recruiting
Clinical Research Institute of Arizona, LLC | Surprise, Arizona, 85374, United States Recruiting Jamie Foreman 623-223-1580 [email protected] Jalal Abbas, MD Principal Investigator
Carondelet Heart and Vascular Institute - Cardiology East | Tucson, Arizona, 85710, United States Active, not recruiting
Sparks Regional Medical Center | Fort Smith, Arkansas, 72901, United States Recruiting Brenna Nguyen 479-441-5508 [email protected] Abdul-Nasser Adjei, MD Principal Investigator
NEA Baptist Clinic | Jonesboro, Arkansas, 72401, United States Recruiting Gordon Blake Davis, LPN 870-936-8365 [email protected] Dharmendra V Patel, MD Principal Investigator
Arkansas Heart Hospital | Little Rock, Arkansas, 72211, United States Recruiting Abby Nolan 501-978-3703 [email protected] Michael Huber, MD Principal Investigator
Westside Medical Associates of Los Angeles | Beverly Hills, California, 90211, United States Recruiting Edith Flores 310-289-5221 [email protected] Norman E Lepor, MD Principal Investigator
Harbor-UCLA Medical Center | Carson, California, 90509, United States Recruiting Olga Barillas 310-781-3622 [email protected] William J French, MD Principal Investigator
Valley Clinical Trials, Inc. | Covina, California, 91723, United States Recruiting Lisa Nakatani 626-915-4702 [email protected] Fahed Bitar, MD Principal Investigator
TriWest Research Associates, LLC | El Cajon, California, 92020, United States Active, not recruiting
California Heart Specialists | Huntington Beach, California, 92648, United States Active, not recruiting
First Valley Medical Group | Lancaster, California, 93534, United States Active, not recruiting
Healthcare Partners Affiliation Medical Group | Long Beach, California, 90806, United States Terminated
Axis Clinical Trials | Los Angeles, California, 90036, United States Terminated
St. Joseph Heritage-Healthcare | Mission Viejo, California, 92691, United States Recruiting Sonia Cummings 949-364-3612 1210 [email protected] Michael Miyamoto, MD Principal Investigator
Radin Cardiovascular Medical Group, Inc. | Newport Beach, California, 92663, United States Recruiting Adrian Flores 714-469-0542 [email protected] Michael Radin, M.D. Principal Investigator
Valley Clinical Trials, Inc. | Northridge, California, 91325, United States Recruiting Julie Toven 818-280-4220 [email protected] Masoud M Azizad, MD Principal Investigator
Pasadena Clinical Research | Pasadena, California, 91105, United States Recruiting Julie Toven 818-280-4220 208 [email protected] Christopher G Chow, MD Principal Investigator
Eugene Soroka, MD Inc. | Port Hueneme, California, 93041, United States Active, not recruiting
VA San Diego Health Care System | San Diego, California, 92161, United States Recruiting Tiffany Hancock 858-642-1129 [email protected] William F Penny Jr, MD Principal Investigator
Interventional Cardiology Medical Group | West Hills, California, 91307, United States Recruiting Michael Fam 818-235-7104 [email protected] Farhad Rafii, M.D. Principal Investigator
South Denver Cardiology Associates, PC | Littleton, Colorado, 80120, United States Recruiting Sue Derbyshire, RN, BSN 303-703-2124 [email protected] Ira Dauber, MD Principal Investigator
Danbury Hospital | Danbury, Connecticut, 06810, United States Recruiting Akshara Patel 203-739-4990 [email protected] Carol Gemayel-Barra, MD Principal Investigator
Stamford Hospital | Stamford, Connecticut, 06904, United States Active, not recruiting
Christiana Care | Newark, Delaware, 19718, United States Recruiting Deborah Moore 302-733-4761 [email protected] Sourin Banerji, MD Principal Investigator
Alfieri Cardiology | Wilmington, Delaware, 19803, United States Active, not recruiting
Cardiology Associates of South Florida | Boynton Beach, Florida, 33472, United States Recruiting Neal Patel 561-351-7822 [email protected] Lawrence Weinstein, MD Principal Investigator
Cardiovascular & Vein Center of Florida | Bradenton, Florida, 34209, United States Recruiting Megan Brady, RN 941-792-1717 [email protected] Eulogio J Sanchez, MD Principal Investigator
Innovative Research of West Florida, Inc. | Clearwater, Florida, 33756, United States Recruiting Lori Sheets 727-584-6368 [email protected] Miguel E Trevino, MD Principal Investigator
Avail Clinical Research, LLC | DeLand, Florida, 32720, United States Recruiting Gail Lavine, LPN 386-785-2400 [email protected] Bruce Rankin, DO Principal Investigator
Riverside Clinical Research | Edgewater, Florida, 32132, United States Recruiting Dawn Millard, CRC 386-428-7730 [email protected] Surya Rao, MD Principal Investigator
Memorial Regional Hospital | Hollywood, Florida, 33021, United States Recruiting Ricardo Guedes 954-265-4185 [email protected] Ioana Dumitru, MD Principal Investigator
St. Vincent's Healthcare - Riverside | Jacksonville, Florida, 32204, United States Recruiting Meghann Wheeler 904-308-5762 [email protected] Raguveer Murthy, MD Principal Investigator
UF Health Jacksonville | Jacksonville, Florida, 32209, United States Recruiting Elizabeth Rhodes, BSN 904-244-2092 [email protected] Francesco Franchi, MD Principal Investigator
St. Vincent's Healthcare - Southside Recruiting | Jacksonville, Florida, 32216, United States Recruiting Kayla Vinson 904-308-5761 [email protected] Ambar M Patel, MD Principal Investigator
Mayo Clinic Florida | Jacksonville, Florida, 32224, United States Recruiting Prachi Kulahalli, CCRC 904-953-8268 [email protected] Shahyar Gharacholou, MD Principal Investigator
Empire Clinical Research, LLC | Miami Lakes, Florida, 33016, United States Terminated
ProLive Medical Research | Miami, Florida, 33130, United States Active, not recruiting
Cordova Research Institute, LLC | Miami, Florida, 33155, United States Recruiting Yaquelin Rodriguez 786-631-3890 [email protected] Jesus Rodriguez de la Torre, MD Principal Investigator
Med-Care Research | Miami, Florida, 33165, United States Recruiting Daniela Urra 305-221-0660 [email protected] Felix Chion-Fong, MD Principal Investigator
ITB Research | Miami, Florida, 33173, United States Active, not recruiting
Vista Health Research | Miami, Florida, 33176, United States Recruiting Jessica Palacio 786-636-6695 [email protected] Antonio Blanco, MD Principal Investigator
Florida Hospital Transplant Institute | Orlando, Florida, 32804, United States Active, not recruiting
Cardiology Partners Clinical Research Institute | Palm Beach Gardens, Florida, 33410, United States Recruiting Kathryn Jones, RN 561-624-2315 [email protected] Duccio Baldari, MD Principal Investigator
Springfield Medical Center | Panama City, Florida, 32401, United States Recruiting Gulafshan Khan, MD 850-785-9511 [email protected] Misal Khan, MD Principal Investigator
Broward Research Center | Pembroke Pines, Florida, 33024, United States Recruiting Noemy Barberan, CCRP 954-482-4290 403 [email protected] Gladys Andrade, MD Principal Investigator
South Florida Research Solutions, LLC | Pembroke Pines, Florida, 33026, United States Recruiting Smelda Ferrin [email protected] Denise Spiller, D.O. Principal Investigator
Cardiology Consultants | Pensacola, Florida, 32501, United States Recruiting Bridget Lane, RN, BSN 850-430-7062 [email protected] Brent D Videau, MD Principal Investigator
Avanza Medical Research Center | Pensacola, Florida, 32503, United States Recruiting Crystal Crump 850-972-9324 2108 [email protected] Rohit Amin, MD Principal Investigator
Professional Health Care of Pinellas | Saint Petersburg, Florida, 33713, United States Recruiting Christina Kerbaj 727-820-1033 [email protected] Fadi E Saba, MD Principal Investigator
Indian River Medical Center | Vero Beach, Florida, 32960, United States Recruiting Simone Williamson 772-778-8687 [email protected] Seth Baker, DO Principal Investigator
Cardiology Partners Clinical Research Institute | Wellington, Florida, 33449, United States Recruiting Janine Cacciatore, RN 561-906-4161 [email protected] Neerav Shah, MD Principal Investigator
Piedmont Heart Institute - Athens | Athens, Georgia, 30606, United States Recruiting Heather Keperling 706-475-1700 [email protected] Catherine Marti, M.D. Principal Investigator
Piedmont Heart Institute | Atlanta, Georgia, 30309, United States Recruiting Kristina Picardi 404-605-2409 [email protected] Arun Krishnamoorthy, M.D. Principal Investigator
University Cardiology Associates, LLC | Augusta, Georgia, 30901, United States Recruiting Jennifer Hansen 706-288-1461 [email protected] Arthur B Chandler, MD Principal Investigator
Augusta University | Augusta, Georgia, 30912, United States Active, not recruiting
Piedmont Heart Institute Fayetteville | Fayetteville, Georgia, 30214, United States Recruiting Lorraine Trim 404-605-2982 [email protected] Andrew Darlington, D.O. Principal Investigator
Georgia Arrhythmia Consultants and Research Institute | Macon, Georgia, 31201, United States Recruiting Andrea Law 478-755-1560 [email protected] Felix O Sogade, MD Principal Investigator
Mercer University | Macon, Georgia, 31201, United States Recruiting Michelle Damron, RN 478-301-5813 [email protected] Jeffrey Stephens, MD Principal Investigator
Atlanta Vanguard Research Institute | Smyrna, Georgia, 30082, United States Active, not recruiting
Saint Luke's Boise Medical Center | Boise, Idaho, 83712, United States Recruiting Sheri LaMott 208-388-7215 [email protected] David Hinchman, MD Principal Investigator
Mount Sinai Hospital Medical Center - Department of Cardiology | Chicago, Illinois, 60608, United States Recruiting Biljana Toshanova 872-222-7380 Sandeep Kholsa, M.D Principal Investigator
Medicoricium, LLC | Fairview Heights, Illinois, 62208, United States Recruiting Elizabeth Capasso-Gulve, PA-C 618-222-8900 [email protected] Omar Almousalli, MD Principal Investigator
Parkview Research Center | Fort Wayne, Indiana, 46845, United States Recruiting Sue Budzon, RN, CCRC 260-266-5617 [email protected] Roy W Robertson, MD Principal Investigator
Franciscan Physician Network - Indiana Heart Physicians | Indianapolis, Indiana, 46237, United States Recruiting Angela Canfield, RN 317-893-1948 [email protected] Michael Barron, MD Principal Investigator
St. Vincent Medical Group | Indianapolis, Indiana, 46260, United States Recruiting Jenny Ferree 317-338-6666 [email protected] Ashwin Ravichandran, MD Principal Investigator
Indiana University Health Ball Memorial Hospital, Inc. | Muncie, Indiana, 47303, United States Active, not recruiting
Reid Physician Associates / Reid Health | Richmond, Indiana, 47374, United States Recruiting Nancy Fry 765-962-1337 6457 [email protected] John McGinty, MD Principal Investigator
Beacon Medical Group Advanced Cardiovascular Specialists | South Bend, Indiana, 46601, United States Recruiting Sandra Charles 574-647-6584 [email protected] John F Kobayashi, MD Principal Investigator
Alexandria Cardiology Clinic | Alexandria, Louisiana, 71301, United States Recruiting Crystal DuBois 318-473-4613 227 [email protected] Naseem Jaffrani, MD Principal Investigator
Heart Clinic of Hammond | Hammond, Louisiana, 70403, United States Recruiting Cheryl Firmin 985-269-7106 [email protected] Ghiath Mikdadi, MD Principal Investigator
Cardiovascular Institute of the South | Houma, Louisiana, 70360, United States Active, not recruiting
Tulane Heart & Vascular Institute | New Orleans, Louisiana, 70112, United States Active, not recruiting
Ochsner Health System | New Orleans, Louisiana, 70121, United States Active, not recruiting
Louisiana Heart Center | Slidell, Louisiana, 70458, United States Recruiting Amy Adams 985-649-2700 [email protected] Bruce J Iteld, MD Principal Investigator
Maine Medical Partners Maine Health Cardiology | Scarborough, Maine, 04074, United States Recruiting Brenda Glasgow 207-885-9905 [email protected] Samuel T Coffin, MD Principal Investigator
Anne Arundel Health System Research Institute | Annapolis, Maryland, 21401, United States Recruiting Jaci Miller, RN 443-481-5868 [email protected] James Welker, DO Principal Investigator
Sinai Hospital of Baltimore | Baltimore, Maryland, 21215, United States Recruiting Ashwin Mahajan 410-601-9135 [email protected] Chaitanya Ravi, MD Principal Investigator
Suburban Hospital | Bethesda, Maryland, 20814, United States Recruiting Alexis Edwards 301-896-2672 [email protected] Gregory Kumkumian, MD Principal Investigator
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States Recruiting Liana Brooks 636-368-7932 [email protected] Erin Coglianese, MD Principal Investigator
Beth Israel Deaconess Medical Center | Boston, Massachusetts, 02215, United States Recruiting Jenifer Kaufman, RN, MS 617-632-8956 [email protected] Marwa Sabe, MD Principal Investigator
NECCR Prima Care Research, LLC | Fall River, Massachusetts, 02721, United States Recruiting Linda Francoeur 508-672-7450 22 [email protected] Ehab Sorial, MD Principal Investigator
Genesys Regional Medical Center | Grand Blanc, Michigan, 48439, United States Active, not recruiting
Western Michigan University Homer Stryker M.D. School of Medicine | Kalamazoo, Michigan, 49008, United States Active, not recruiting
Michigan CardioVascular Institute at Covenant Medical Center | Saginaw, Michigan, 48602, United States Recruiting Patricia Cordingly 989-907-4187 [email protected] Rajeev Sudhakar, MD Principal Investigator
Allina Health System, dba Abbott Northwestern Hospital | Minneapolis, Minnesota, 55407, United States Recruiting Sarah Schwager 612-863-6286 [email protected] Peter Eckman, MD Principal Investigator
Mayo Clinic | Rochester, Minnesota, 55905, United States Recruiting Sue Milbrandt 507-538-6105 [email protected] Margaret Redfield, MD Principal Investigator
Cardiology Associates Research, LLC | Tupelo, Mississippi, 38801, United States Recruiting Kelly Hollis, RN, BSN 662-620-6835 [email protected] Barry Bertolet, MD Principal Investigator
North Kansas City Hospital | North Kansas City, Missouri, 64116, United States Recruiting Julie Dehner 816-691-5373 [email protected] David M Hahn, MD Principal Investigator
St. Louis Heart & Vascular, PC | Saint Louis, Missouri, 63136, United States Recruiting Stacey Miner 314-741-0911 [email protected] Gil Vardi, MD Principal Investigator
Nebraska Heart Institute | Lincoln, Nebraska, 68526, United States Active, not recruiting
CHI Health Research Center | Omaha, Nebraska, 68124, United States Active, not recruiting
University Medical Center of Southern Nevada | Las Vegas, Nevada, 89102, United States Recruiting Jennifer Robinson 702-383-7842 [email protected] Chowdhury Ahsan, M.D. Principal Investigator
Red Rock Clinical Research, LLC | Las Vegas, Nevada, 89146, United States Active, not recruiting
Monmouth Cardiology Associates, LLC | Eatontown, New Jersey, 07724, United States Recruiting Karin Soucy 732-807-2170 [email protected] Lance Berger, MD Principal Investigator
Englewood Health | Englewood, New Jersey, 07631, United States Active, not recruiting
Advanced Heart & Vascular Institute of Hunterdon | Flemington, New Jersey, 08822, United States Recruiting Robin Enea 908-237-3405 [email protected] Andrey Espinoza, MD Principal Investigator
Hackensack University Medical Center | Hackensack, New Jersey, 07601, United States Active, not recruiting
Saint Peter's University Hospital | New Brunswick, New Jersey, 08901, United States Active, not recruiting
Saint Michael's Medical Center | Newark, New Jersey, 07102, United States Recruiting Raymond Monel 973-877-2764 [email protected] Abbas Shehadeh, MD Principal Investigator
Rutgers New Jersey Medical School | Newark, New Jersey, 07103, United States Active, not recruiting
AtlantiCare Regional Medical Center | Pomona, New Jersey, 08240, United States Recruiting Jackie White, RN 609-404-7654 [email protected] Vineshkumar Patel, MD Principal Investigator
The Valley Hospital | Ridgewood, New Jersey, 07450, United States Active, not recruiting
Cardio Metabolic Institute | Somerset, New Jersey, 08873, United States Active, not recruiting
Holy Name Medical Center | Teaneck, New Jersey, 07666, United States Active, not recruiting
New York Presbyterian Brooklyn Methodist Hospital | Brooklyn, New York, 11215, United States Recruiting Mahmoud Mohamed, MD 718-780-5616 [email protected] John Heitner, MD Principal Investigator
Trinity Medical WNY, PC | Cheektowaga, New York, 14227, United States Recruiting Elizabeth Hejna 716-835-2966 [email protected] Michael J Hong, MD Principal Investigator
Mount Sinai Hospital | New York, New York, 10029, United States Recruiting Brendon Keith 212-241-3507 [email protected] Anuradha Lala-Trindade, MD Principal Investigator
Rochester General Hospital | Rochester, New York, 14621, United States Recruiting Megan Littleton 585-922-3536 [email protected] Vishal Parikh, MD Parikh, MD Principal Investigator
Richmond University Medical Center | Staten Island, New York, 10310, United States Recruiting Adnan Nasir 718-818-2707 [email protected] Richard Grodman, MD Principal Investigator
Stony Brook University Hospital | Stony Brook, New York, 11794-7007, United States Recruiting Pooja Shukla, PhD 631-444-7238 Hal A Skopicki, MD Principal Investigator
Circuit Clinical | West Seneca, New York, 14224, United States Recruiting Andrew T Haynes, CCRC 716-341-0051 [email protected] David Avino, D.O. Principal Investigator
Northtowns Cardiology, PLLC | Williamsville, New York, 14221, United States Active, not recruiting
Asheville Cardiology Associates | Asheville, North Carolina, 28803, United States Recruiting Amber Hull, RN 828-274-6000 1048777 [email protected] Benjamin Trichon, MD Principal Investigator
Duke University Heart Failure Research | Durham, North Carolina, 27710, United States Recruiting Jennifer Wilson 919-668-8222 [email protected] Paul Rosenberg, MD Principal Investigator
Medication Management, LLC | Greensboro, North Carolina, 27401, United States Recruiting Lauren Talton 336-763-6968 [email protected] Jagadeesh Ganji, MD Principal Investigator
Wake Forest University Health Sciences | High Point, North Carolina, 27262, United States Recruiting Ginger Leonard 336-885-6168 [email protected] Thomas Folk, MD Principal Investigator
Duke Cardiology of Lumberton | Lumberton, North Carolina, 28358, United States Recruiting Nicole Scott 910-272-7248 [email protected] William Herzog Jr, MD Principal Investigator
Monroe Biomedical Research | Monroe, North Carolina, 28112, United States Recruiting Jennifer Norton 704-283-7359 [email protected] David Smith, MD Principal Investigator
Crossroads Clinical Research, Inc. | Mooresville, North Carolina, 28117, United States Recruiting Judith Kennedy 704-360-9310 107 [email protected] Elmer H Stout, MD Principal Investigator
Pinehurst Medical Clinic, Inc. | Pinehurst, North Carolina, 28374, United States Recruiting Rebecca Meyer 910-235-3144 [email protected] Patrick Simpson, MD Principal Investigator
NC Heart & Vascular Research | Raleigh, North Carolina, 27607, United States Recruiting Patty Gothard 919-784-3413 [email protected] Christopher Chien, MD Principal Investigator
WakeMed Health and Hospitals | Raleigh, North Carolina, 27610, United States Recruiting LaMonica Daniel 919-231-6132 421 [email protected] Stuart D Russell, MD Principal Investigator
PMG Research of Wilmington | Wilmington, North Carolina, 28401, United States Recruiting Marcus Albert 910-815-6108 [email protected] Matthew J Janik, MD Principal Investigator
Trinity Health Center - Medical Arts | Minot, North Dakota, 58701, United States Recruiting Natalie Quam 701-857-2510 [email protected] Samir Turk, MD Principal Investigator
Aultman Cardiology Clinical Trials | Canton, Ohio, 44710, United States Recruiting Jeannie Archinal, RN 330-363-7277 [email protected] John Prodafikas, MD Principal Investigator
The MetroHealth System | Cleveland, Ohio, 44109, United States Recruiting Mary Ann Shella, RN 216-778-3704 [email protected] Khalil Murad, MD Principal Investigator
The Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States Recruiting Lauren Ives 216-444-9066 [email protected] Jerry Estep, MD Principal Investigator
The Ohio State University | Columbus, Ohio, 43210, United States Recruiting Roger Faubel 614-292-5462 [email protected] Sitaramesh Emani, MD Principal Investigator
North Ohio Heart Center | Elyria, Ohio, 44035, United States Recruiting Judy Fritsch 440-414-9130 [email protected] Ademola K Abiose, MD Principal Investigator
North Ohio Heart Center | Sandusky, Ohio, 44870, United States Recruiting Karlene Humphrey, RN 440-414-9331 [email protected] William P McGuinn, MD Principal Investigator
Heart House Research Foundation | Springfield, Ohio, 45505, United States Recruiting Teresa Bruner 937-323-1404 [email protected] Sayed MT Rizvi, MD Principal Investigator
South Oklahoma Heart Research, LLC | Oklahoma City, Oklahoma, 73135, United States Recruiting Kay Springer 405-628-6756 [email protected] Naeem Khan Tahirkheli, MD Principal Investigator
Abington Memorial Hospital | Abington, Pennsylvania, 19001, United States Recruiting Colleen Marchand 215-481-4661 [email protected] Donald C Haas, MD Principal Investigator
Penn State Health Holy Spirit Medical Center Geisinger - Cardiology | Camp Hill, Pennsylvania, 17011, United States Recruiting Nicole Grassmyer, BSN, RN 717-724-6304 [email protected] Rejesh Dave, MD Principal Investigator
Lancaster General Hospital | Lancaster, Pennsylvania, 17602, United States Recruiting Lou Anne Kruse, RN, BSN 717-544-1777 [email protected] Amit Varma, MD Principal Investigator
Drexel University | Philadelphia, Pennsylvania, 19102, United States Active, not recruiting
Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Active, not recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine | Philadelphia, Pennsylvania, 19104, United States Active, not recruiting
V.A. Pittsburgh Healthcare System | Pittsburgh, Pennsylvania, 15240, United States Recruiting Eve Kellar, RN 412-360-6230 [email protected] Alaa Shalaby, MD Principal Investigator
Prisma Health | Columbia, South Carolina, 29203, United States Recruiting Lauren Nixon 803-434-3800 53891 [email protected] Patrick McCann, MD Principal Investigator
Self Regional Hospital Research Center | Greenwood, South Carolina, 29646, United States Recruiting Heather Rich 864-943-2416 [email protected] Priya Kumar, MD Principal Investigator
Carolina Heart Specialists | Lancaster, South Carolina, 29720, United States Recruiting Emad Ghaly 803-285-2041 [email protected] Vipul Shah, MD Principal Investigator
Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc. | Rapid City, South Dakota, 57701, United States Recruiting Denice Hockett, RN 605-755-4326 [email protected] Alexander Schabauer, MD Principal Investigator
Stern Cardiovascular Foundation | Germantown, Tennessee, 38138, United States Recruiting Kay Loyd [email protected] Frank McGrew,III, MD Principal Investigator
Stern Cardiovascular Foundation | Germantown, Tennessee, 38138, United States Recruiting Kay Loyd 901-226-0476 [email protected] Frank McGrew, III, MD Principal Investigator
Tennova Healthcare-Turkey Creek Medical Center | Knoxville, Tennessee, 37934, United States Recruiting Beth Polk, RN 865-818-7535 [email protected] Malcolm T Foster, MD Principal Investigator
Parkway Cardiology Associates, PC | Oak Ridge, Tennessee, 37830, United States Recruiting Chasity White, RN 865-482-4078 263 [email protected] Milan Sheth, DO Principal Investigator
Amarillo Hearth Clinical Research Institute, Inc. | Amarillo, Texas, 79106, United States Recruiting Leticia Mincher, RN 806-463-2153 [email protected] Alan Chu, MD Principal Investigator
PharmaTex Research | Amarillo, Texas, 79106, United States Recruiting Casey Mizer, CRC 806-355-2581 [email protected] Sammy L Cox, MD Principal Investigator
Dallas VA Medical Center | Dallas, Texas, 75216, United States Recruiting Rahel Iwnetu 214-857-1637 [email protected] Shuaib Abdullah, M.D. Principal Investigator
Cardiovascular Research Institute of Dallas | Dallas, Texas, 75231, United States Recruiting Denise Daniel 214-360-0869 [email protected] Martin R Berk, MD Principal Investigator
Southwest Family Medicine Associates | Dallas, Texas, 75235, United States Recruiting Safia Shaikh 214-393-2940 [email protected] Chrisette Dharma, MD Principal Investigator
Baylor University Medical Center | Dallas, Texas, 75246, United States Recruiting Michelle Clark, RN 214-820-1722 [email protected] Shelley Hall, MD Principal Investigator
Texas Health Research & Education Institute | Fort Worth, Texas, 76104, United States Active, not recruiting
Texas Heart Institute | Houston, Texas, 77030, United States Recruiting Sylvia Carranza 832-355-8524 [email protected] Reynolds Delgado, MD Principal Investigator
Houston Heart & Vascular Associates | Kingwood, Texas, 77339, United States Recruiting Holly Little 281-312-0242 [email protected] Raymond Little, MD Principal Investigator
Caprock Cardiac Center Research Institute, Inc. | Lubbock, Texas, 79410, United States Terminated
Angelina Medical Research, LLC | Lufkin, Texas, 75904, United States Recruiting Jessica Smith 936-634-0180 [email protected] Terry L Wells, MD Principal Investigator
North Dallas Research Associates | McKinney, Texas, 75069, United States Recruiting Irfan Ullah 972-562-2345 Muhammad A Khan, MD, MBA Principal Investigator
North Texas Research Associates | McKinney, Texas, 75701, United States Recruiting Ahmed Ladak 214-544-3355 [email protected] Faizan Iftikhar, MD Principal Investigator
South Texas Cardiovascular Consultants, PLLC | San Antonio, Texas, 78201, United States Recruiting Stephanie Cardenas, LVN 210-635-1690 [email protected] Jamil A Malik, MD Principal Investigator
Baylor Scott & White Medical Center | Temple, Texas, 76508, United States Recruiting Margarite Grable 254-724-5861 [email protected] Lazaros Nikolaidis, MD Principal Investigator
PharmaTex Research | Tyler, Texas, 75701, United States Recruiting Holly Cade 903-570-4744 [email protected] Thomas Buzbee, MD Principal Investigator
The University of Texas Health Center at Tyler | Tyler, Texas, 75708, United States Active, not recruiting
Wichita Falls Heart Clinic | Wichita Falls, Texas, 76301, United States Recruiting Ciarra Heard 940-264-3216 [email protected] Vedampattu Ganeshram, MD Principal Investigator
Advanced Clinical Research/Intermountain Heart Center PC | West Jordan, Utah, 84088, United States Recruiting Zac Colton 801-542-8190 [email protected] Stephen Miller, MD Principal Investigator
The University of Vermont Medical Center | Burlington, Vermont, 05401, United States Recruiting Marilynn Roth, RN 802-847-4746 [email protected] Peter Van Buren, MD Principal Investigator
Stroobants Cardiovascular Center | Lynchburg, Virginia, 24501, United States Recruiting Joyce White, MSN 434-200-2799 [email protected] Brian Schietinger, MD Principal Investigator
Riverside Cardiology Specialists | Newport News, Virginia, 23601, United States Recruiting Virginia Barch 757-594-4508 [email protected] Edward Chu, MD Principal Investigator
Sentara Norfolk General Hospital | Norfolk, Virginia, 23507, United States Recruiting Jordan Dail, RN 757-388-7511 [email protected] David Baran, M.D. Principal Investigator
Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J) | Richmond, Virginia, 23249, United States Recruiting 804-675-5421 Neil Lewis, MD Principal Investigator
VCU Medical Center | Richmond, Virginia, 23298, United States Active, not recruiting
Carilion Medical Center | Roanoke, Virginia, 24014, United States Recruiting Christina Bryant 540-526-6701 [email protected] David Sane, MD Principal Investigator
Selma Medical Associates | Winchester, Virginia, 22601, United States Recruiting Peggy Gruenther 540-678-2838 [email protected] Philip O' Donnell MD, MD Principal Investigator
Providence Regional Medical Center Everett | Everett, Washington, 98201, United States Recruiting Courtney Nichols 425-261-3544 [email protected] Vivek Bhatia, MD Principal Investigator
Swedish Heart & Vascular-Advanced Cardiac Support Program | Seattle, Washington, 98122, United States Active, not recruiting
Providence Sacred Heart Medical Center & Children's Hospital | Spokane, Washington, 99204, United States Recruiting Lisa Davis, CCRC 509-474-3821 [email protected] Bryan E Fuhs, MD Principal Investigator
CHI Franciscan Research Center | Tacoma, Washington, 98405, United States Active, not recruiting
Walla Walla Clinic | Walla Walla, Washington, 99362, United States Active, not recruiting
Wenatchee Valley Hospital & Clinics | Wenatchee, Washington, 98801, United States Recruiting Eliza Del Rocio Zuniga 509-665-5800 [email protected] Guatum S Nayak, MD Principal Investigator
Marshfield Clinic | Marshfield, Wisconsin, 54449, United States Active, not recruiting
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States Recruiting Rachel Ambroch, BS, NREMT 414-955-7050 [email protected] Nunzio Gaglianello, MD Principal Investigator
ProHealth Care Inc / Waukesha Memorial Hospital | Waukesha, Wisconsin, 53188, United States Recruiting Rita Shetty 262-928-7637 [email protected] Matthew Weinberg, MD Principal Investigator
SWSLHD-Liverpool Hospital | Liverpool, New South Wales, 1871, Australia Recruiting Rosa Lee +61 2 8738 3998 [email protected] Gayathri Kumarasinghe, MD Principal Investigator
Sunshine Coast University Hospital | Birtinya, Queensland, 4575, Australia Recruiting Samantha Wadham 61752023056 [email protected] Matthew Marrinan, MD Principal Investigator
Cairns Hospital | Cairns, Queensland, 4870, Australia Recruiting Sue Dixon 07 4226 8990 [email protected] Steven Sutcliffe, MD Principal Investigator
The Prince Charles Hospital | Chermside, Queensland, 4032, Australia Recruiting Suzanne Spencer +617 3139 4711 [email protected] Yee W Wong, MD Principal Investigator
Core Research Group | Milton, Queensland, 4064, Australia Recruiting Hennie Venter 61 7 3876 5688 [email protected] David M Colquhoun, MD Principal Investigator
Gold Coast University Hospital | Southport, Queensland, 4215, Australia Recruiting Tracey Brumby 0412 982 355 [email protected] Laurie Howes, MD Principal Investigator
The Queen Elizabeth Hospital | Adelaide, South Australia, 5011, Australia Recruiting Greer Dymott +61 8 8222 7907 [email protected] Alicia Chan, MD Principal Investigator
SA Heart | Ashford, South Australia, 5035, Australia Active, not recruiting
Flinders Medical Centre | Bedford Park, South Australia, 5042, Australia Recruiting Chris Hincks 08 8404 2001 [email protected] Carmine De Pasquale, MD Principal Investigator
Lyell McEwin Hospital | Elizabeth Vale, South Australia, 5112, Australia Recruiting Bernadette Hoffmann 0409665851 [email protected] Alicia Chan, MD Principal Investigator
Heart Lung Clinic | Darlinghurst, Sydney, Australia Recruiting Carmen Herrera +61 02 83823025 [email protected] Prof. Peter Macdonald, MD Principal Investigator
Royal Hobart Hospital | Hobart, Tasmania, 7000, Australia Recruiting Gaynor Cherry 61 3 61667881 [email protected] Nathan Dwyer, MD Principal Investigator
Royal Adelaide Hospital | Adelaide, 5000, Australia Recruiting Stephanie Zrim 08 7074 0000 [email protected] Michael Stokes, MD Principal Investigator
Macquarie University - Clinical Trials Unit | Macquarie Park, 2109, Australia Recruiting Natalia Inness [email protected] Martin R. Brown, MBBS Principal Investigator
John Hunter Hospital | New Lambton Heights, 2305, Australia Recruiting Dr. Aaron Sverdlov Principal Investigator
Epworth HealthCare Clinical Trials | Richmond, 3121, Australia Recruiting Jayne Damm 03 9936 8068 [email protected] Hendrik Zimmet, MBBS Principal Investigator
MHAT Puls | Blagoevgrad, 2700, Bulgaria Recruiting Yordan Dzhumean, MD Principal Investigator
Multiprofile Hospital for Active Treatment: Department of cardiology | Gabrovo, 5300, Bulgaria Recruiting Tota Venkova, MD Dr. Miroslav Stoyanov Principal Investigator
MHAT Haskovo AD | Haskovo, 6304, Bulgaria Recruiting Ivaylo Vasilev, MD Principal Investigator
Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology | Lom, 3600, Bulgaria Recruiting Ivan Efremov, M.D. Principal Investigator
Medical Center Medconsult Pleven OOD | Pleven, 5800, Bulgaria Recruiting Maria Tzekova, M.D., PhD Principal Investigator
МC Hipokrena | Sevlievo, 5400, Bulgaria Recruiting Tanya Petkova, MD Principal Investigator
Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology | Sofia, 1113, Bulgaria Recruiting Ivan Martinov, M.D. Principal Investigator
Second Medical Center-Sofia, EEOD - Department of Cardiology | Sofia, 1202, Bulgaria Recruiting Katarina Vitliyanova, M.D. Principal Investigator
Second Multiprofile Hospital for Active Treatment | Sofia, 1202, Bulgaria Recruiting Georgi Todorov, M.D Principal Investigator
5th City Hospital | Sofia, 1233, Bulgaria Recruiting Bojidar Dimov, MD Principal Investigator
National Multiprofile Transport Hospital Cardiology Clinic | Sofia, 1233, Bulgaria Recruiting Valentina M Kabakchieva, M.D., Ph.D Principal Investigator
Medical Center Hera EOOD - Office of Cardiology | Sofia, 1510, Bulgaria Recruiting Valentina Grigorova, M.D. Principal Investigator
Multiprofile Regional Hospital for Active Treatment | Veliko Tarnovo, 5002, Bulgaria Recruiting Haralambi Benov, M.D. Principal Investigator
Medical Center Velingrad 2017" EOOD, Office of Cardiology | Velingrad, 4600, Bulgaria Recruiting Savka Vaklyova Principal Investigator
University of Calbary | Calgary, Alberta, T2N 4Z6, Canada Recruiting Kim Ronak 403-220-8282 [email protected] Brian Clarke, MD Principal Investigator
University of Alberta Hospital | Edmonton, Alberta, T6G 2B7, Canada Recruiting Quentin Kushnerik 780-407-3535 [email protected] Justin Ezekowitz, MBBCh Principal Investigator
South Edmonton Cardiology Consultants | Edmonton, Alberta, T6L 6K3, Canada Active, not recruiting
Royal Alexandria Hospital | Edmonton, Alberta, Canada Recruiting Elaine Tabanguil 780-613-5008 [email protected] Marc Benoit, MD Principal Investigator
Fraser Clinical Trials | New Westminster, British Columbia, V3L 3W4, Canada Recruiting Sandi Thiessen 604.521.4500 [email protected] Richard Vandegriend, MD Principal Investigator
SMH Cardiology Clinical Trials | Surrey, British Columbia, V3V 0C6, Canada Recruiting Tracy Cleveland 604-584-3720 [email protected] Dante Manyari, M.D. Principal Investigator
St. Paul's Hospital | Vancouver, British Columbia, V6E 1M7, Canada Recruiting Carol Marchand 604-806-8804 [email protected] Mustafa Toma, MD Principal Investigator
Victoria Heart Institute Foundation | Victoria, British Columbia, V8R 4R2, Canada Recruiting Georgette Morgen 250-595-1884 [email protected] Elizabeth Swiggum, MD Principal Investigator
G.A. Research Associates, Ltd. | Moncton, New Brunswick, Canada Recruiting Katherine Reid 506-852-9865 [email protected] Ronald Bourgeois, MD Principal Investigator
Health Sciences Centre | Saint John's, Newfoundland and Labrador, A1B 3V6, Canada Recruiting Jill Cole, RN 709-777-6996 [email protected] Bruce Sussex, MD Principal Investigator
Nova Scotia Health Authority | Halifax, Nova Scotia, B3H 3A7, Canada Recruiting Jayne Falkenham, RN 902-473-2732 [email protected] Miroslaw Rajda, MD Principal Investigator
Manna Research Inc., Burlington South | Burlington, Ontario, L7R 1A4, Canada Active, not recruiting
Cambridge Cardiac Care Center | Cambridge, Ontario, N1R 6V6, Canada Recruiting Jacqueline Lake 519-624-3511 [email protected] Shekhar Pandey, MD Principal Investigator
Vizel Cardiac Research | Cambridge, Ontario, N1R 7R1, Canada Recruiting Beverly Fox 519-622-0067 [email protected] Saul Vizel, MD Principal Investigator
London Health Sciences Center (LHSC) | London, Ontario, N6A 5A5, Canada Recruiting Sandy Carr, RN 519-663-3728 [email protected] Ryan Davey, MD Principal Investigator
St. Michael's Hospital | Toronto, Ontario, M5B 1W8, Canada Recruiting Carlos Fernando 416-864-6060 2886 [email protected] Gordon Moe, MD Principal Investigator
Sinai Health System - Mount Sinai Hospital | Toronto, Ontario, M5G 1X5, Canada Recruiting Elaine Hsu 416-586-4497 [email protected] John Parker, MD Principal Investigator
Clinique de Cardiologie de Lévis | Lévis, Quebec, G6V 4Z5, Canada Active, not recruiting
Montreal Heart Institute | Montréal, Quebec, H1T 1C8, Canada Recruiting Maria Ida Dardes 514-376-3330 4056 [email protected] Eileen O'Meara, MD Principal Investigator
McGill University Health Centre (MUHC) | Montréal, Quebec, H4A 3J1, Canada Recruiting Reza Sahebjamei 514-934-1934 24924 [email protected] Nadia S Giannetti, MD Principal Investigator
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval | Québec, Quebec, G1V 4G5, Canada Recruiting Audrey Grenier 418-656-8711 5429 [email protected] Sébastien Bergeron, MD Principal Investigator
CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges | Saint-Georges, Quebec, G5Y 4T8, Canada Recruiting Émilie Coté 418-228-2031 37279 [email protected] Danielle Dion, MD Principal Investigator
Recherche Medical St-Jerome Inc. | Saint-Jérôme, Quebec, J7Z 5T3, Canada Recruiting Yanick Sardin Laframboise 450-431-1020 [email protected] Yves Pesant, MD Principal Investigator
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec | Trois-Rivières, Quebec, G8Z 3R9, Canada Recruiting Isabelle Roy 819-697-3333 68393 [email protected] Ying Tung Sia, MD Principal Investigator
Royal University Hospital | Saskatoon, Saskatchewan, S7N 0W8, Canada Recruiting Sarah Boyd 306-230-3020 [email protected] Alexander Zhai, MD Principal Investigator
Interni kardiologicka klinika FN Brno | Brno, 625 00, Czechia Recruiting Ondrej Toman, MD Principal Investigator
Kardiologicka ambulance | Chlumec Nad Cidlinou, 50353, Czechia Recruiting - Martin Wiendl, M.D Principal Investigator
Kardiologicka ambulance | Chlumec Nad Cidlinou, 50353, Czechia Recruiting Martin Wiendl, MD Principal Investigator
Centrum preventivní kardiologie, Karlovo nám. 32, | Prague, 128 08, Czechia Recruiting Richard Češka, MD Principal Investigator
Centrum preventivní kardiologie | Prague, 128 08, Czechia Recruiting Prof. Richard Češka, MD Principal Investigator
General University Hospital in Prague | Prague, 128 08, Czechia Recruiting Jan Bělohlávek, MD, PhD. Principal Investigator
General University Hospital | Prague, 128 08, Czechia Recruiting Jan Bělohlávek, MD, Ph.D Principal Investigator
IKEM-Klinika kardiologie | Prague, 140 21, Czechia Recruiting Vojtěch Melenovský, MD Principal Investigator
JSC Evex Hospitals,Georgia | Batumi, 6010, Georgia Recruiting Giorgi Nikolaishvili, M.D., PhD Principal Investigator
Clinic-LJ | Kutaisi, 4600, Georgia Recruiting Zaza Lominadze, MD Principal Investigator
Aleksandre Aladashvili Clinic LLC | Tbilisi, 0102, Georgia Recruiting Irakli Khintibidze, MD, PhD Principal Investigator
Ltd Israel-Georgian Medical Research Clinic "Helsicore" | Tbilisi, 0112, Georgia Recruiting Nodar Emukhvari Principal Investigator
Ltd Pineo Medical Ecosistem | Tbilisi, 0114, Georgia Recruiting Zurab Klimiashvili, M.D. Principal Investigator
Acad. G. Chapidze Emergency Cardiology Center | Tbilisi, 0159, Georgia Recruiting Vakhtang Chumburidze, M.D., PhD Principal Investigator
Bokhua Memorial Cardiovascular Center | Tbilisi, 0159, Georgia Recruiting Rusudan Agladze, M.D., PhD Principal Investigator
Tbilisi Heart and Vascular Clinic | Tbilisi, 0159, Georgia Recruiting Prof. Tamaz Shaburishvili, MD, PhD Principal Investigator
Ltd TIM- Tbilisi Institute of Medicine | Tbilisi, 0160, Georgia Recruiting Levan Kurashvili, M.D. Principal Investigator
Georgian-Dutch Hospital | Tbilisi, 0172, Georgia Recruiting George Khabeishvili, MD, PhD Principal Investigator
Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai | Budapest, 1085, Hungary Recruiting András Papp, MD Principal Investigator
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika | Budapest, 1122, Hungary Recruiting András Nagy,, MD, PhD. Principal Investigator
Debreceni Egyetem Klinikai Központ Kardiológiai Osztály | Debrecen, 4032, Hungary Recruiting Zoltán Csanádi, MD, PhD Principal Investigator
Clinexpert Gyöngyös Kft | Gyöngyös, 3200, Hungary Recruiting Annamária Piros Principal Investigator
Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház | Harkány, 7815, Hungary Recruiting Zénó Ajtay, MD, PhD Principal Investigator
Bács-Kiskun Megyei Kórház Kardiológiai Osztály | Kecskemet, 6000, Hungary Recruiting András Nagy, M.D., Ph.D Principal Investigator
Andrea Hornyik, MD | Miskolc, 3529, Hungary Recruiting Andrea Hornyik, MD Principal Investigator
Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika, | Pecs, 7624, Hungary Recruiting Kálmán Tóth, M.D., Ph.D Principal Investigator
Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály | Szolnok, 5000, Hungary Recruiting Béla Herczeg, MD Principal Investigator
Belvárosi Egészségház Kft | Zalaegerszeg, 8900, Hungary Recruiting Géza Lupkovics, MD, PhD Principal Investigator
Daugavpils Regional Hospital | Daugavpils, LV5417, Latvia Recruiting Natana Kakrina, MD, PhD Principal Investigator
Liepajas Regional Hospital | Liepaja, LV3414, Latvia Recruiting Iveta Sime Principal Investigator
Pauls Stradins Clinical University Hospital | Riga, LV1002, Latvia Recruiting Iveta Mintale, MD, PhD Principal Investigator
Riga East University hospital clinic Gailezers | Riga, LV1038, Latvia Recruiting Artis Kalnins, MD Principal Investigator
The Hospital of Lithuanian | Kaunas, 50161, Lithuania Recruiting Gintare Sakalyte, MD, PhD Principal Investigator
Klaipeda Seaman's Hospital | Klaipėda, 92288, Lithuania Recruiting Dalia Jarasuniene, MD Principal Investigator
Vilnius University Hospital Santaros Klinikos | Vilnius, 08661, Lithuania Recruiting Jelena Celutkiene, MD, PhD Principal Investigator
Wellington Hospital | Newton, Wellington, 6021, New Zealand Recruiting Beverley Scott 64 4 918 5728 [email protected] Alyssa Kirby, MD Principal Investigator
Totara Clinical Research, Health New Lynn | Auckland, 0600, New Zealand Recruiting Craig King, MB ChB Principal Investigator
North Shore Hospital | Auckland, 0622, New Zealand Recruiting Gráinne McAnnalley +6494868920 43591 [email protected] Hamish Hart, MD Principal Investigator
Auckland City Hospital | Auckland, 1023, New Zealand Recruiting Cathrine Patten 64 9 3074949 25848 [email protected] Jocelyne Benatar, MD Principal Investigator
Middlemore Hospital | Auckland, 2025, New Zealand Active, not recruiting
Christchurch Heart Institute | Christchurch, 8140, New Zealand Recruiting Stephanie Rose 64 03 3786137 [email protected] Richard Troughton, MD Principal Investigator
Dunedin Hospital | Dunedin, 9016, New Zealand Recruiting Mary Blok 64 3 4740999 58084 [email protected] Gerard T Wilkins, MD Principal Investigator
Hauora Tairāwhiti Department of Cardiology | Gisborne, 4010, New Zealand Recruiting Gerard P Devlin, MB, BCh Principal Investigator
Hawke's Bay Hospital | Hastings, 4120, New Zealand Recruiting Diana Schmid +64 6 8788109 [email protected] Richard Luke, MD Principal Investigator
Hutt Hospital | Lower Hutt, 5010, New Zealand Recruiting Jo Kovacs +6445872520 [email protected] Timothy O'Meegan, MD Principal Investigator
Nelson Hospital | Nelson, 7010, New Zealand Recruiting Petra Crone +64275209782 [email protected] Tammy Pegg, MD Principal Investigator
Taranaki Base Hospital | New Plymouth, 4310, New Zealand Recruiting Carolyn Jackson 64 67536139 [email protected] Ian Ternouth, MD Principal Investigator
Rotorua Hospital | Rotorua, New Zealand Recruiting Karen Knight +64 7 349 7955 ext. 7722 [email protected] Dr. Susan De Caigney Principal Investigator
Clinical Horizons NEW ZEALAND LTD | Tauranga, 3112, New Zealand Recruiting Tracy Paterson +64 7 571 1492 [email protected] Andrew P Corin, MD Principal Investigator
Oddział Kardiologii WSzS nr 4 | Bytom, 41-902, Poland Recruiting Aleksander Włodarczyk, MD, PhD Principal Investigator
Biokinetica S.A. Przychodnia Józefów | Józefów, 05-410, Poland Recruiting Monika Tomaszewska-Kiecana,, MD Principal Investigator
Centrum Medyczne Linden | Kraków, 30-394, Poland Recruiting Piotr Paluszek, MD, PhD Principal Investigator
1 Wojskowy Szpital Klininiczny w Lublinie | Lublin, 20-049, Poland Recruiting Grzegorz Sobieszek, MD Principal Investigator
Ko-Med Centra Kliniczne | Lublin, 20-362, Poland Recruiting Marzena Janik-Palazzolo, MD Principal Investigator
Szpital Swietej Anny w Miechowie | Miechów, 32-200, Poland Recruiting Maciej Żabówka, MD Principal Investigator
Szpital Świętej Anny w Miechowie | Miechów, 32-200, Poland Recruiting Mariusz Kafara, MD, Ph.D Principal Investigator
Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna | Nowy Dwór Mazowiecki, 05-100, Poland Recruiting Piotr Abramczyk, MD, PhD Principal Investigator
Zespol Opieki Zdrowotnej | Oława, 55-200, Poland Recruiting Ryszard Sciborski, MD, PhD Principal Investigator
Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej | Toruń, 87-100, Poland Recruiting Grzegorz Skonieczny, MD, PhD Principal Investigator
Uniwersyteckie Centrum Kliniczne | Warszawa, 02-097, Poland Recruiting Zbigniew Gaciong, MD, PhD Principal Investigator
Centrum Medyczne K2J2 | Wołomin, 05-200, Poland Recruiting Sławomir Tymiński Principal Investigator
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego | Wrocław, 50-556, Poland Recruiting Joanna Szachniewicz, MD, PhD Principal Investigator
4th Military Hospital | Wrocław, 50-981, Poland Recruiting Bartosz Krakowiak Principal Investigator
Proximum Centrum Usług Medycznych NZOZ | Wrocław, 53-428, Poland Recruiting Marta Obremska, MD, Ph.D Principal Investigator
Marcin Ogórek, MD, PhD | Łódź, 94-048, Poland Recruiting Marcin Ogórek, MD, PhD Principal Investigator
Municipal Autonomous Healthcare Institution "City Clinical Hospital #6 | Chelyabinsk, 454017, Russian Federation Recruiting Anatoly Kuzin, MD Principal Investigator
Municipal Autonomous Healthcare Institution | Chelyabinsk, 454017, Russian Federation Recruiting Anatoly Kuzin, MD Principal Investigator
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases | Kemerovo, 650002, Russian Federation Recruiting Olga Barbarash, MD, PhD Principal Investigator
State Budgetary Healthcare Institution of Moscow city "Moscow | Moscow, 117292, Russian Federation Recruiting Zhanna Kobalava, MD, PhD Principal Investigator
Private Medical Institution "Euromedservice | Pushkin, 196603, Russian Federation Recruiting Irina Shumikhina Principal Investigator
State Budgetary Institution of Ryazan Region | Ryazan, 390026, Russian Federation Recruiting Sergey Yakushin, MD Principal Investigator
JSC Polyclinic Complex | Saint Petersburg, 190013, Russian Federation Recruiting Elizaveta Antonova, MD Principal Investigator
Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital" | Saint Petersburg, 195257, Russian Federation Recruiting Rostislav Nilk, MD, PhD Principal Investigator
LLC "Scientific Research Center Eco-Safety" | Saint Petersburg, 196143, Russian Federation Recruiting Vasily Vasilyuk, MD, PhD Principal Investigator
JSC Polyclinic Complex | Saint-Petersburg, 190013, Russian Federation Recruiting Elizaveta Antonova, MD Principal Investigator
State Healthcare Institution | Saratov, 410002, Russian Federation Recruiting Olga Reshetko, MD PhD Principal Investigator
Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia | Saratov, 410054, Russian Federation Recruiting Yury Grigorievitch Shvarts, M.D., Ph.D Principal Investigator
Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze | St. Petersburg, 192242, Russian Federation Recruiting Victor Kostenko, MD Principal Investigator
Saint Petersburg Research Institute of Emergency Medicine | St. Petersburg, 192242, Russian Federation Recruiting Victor Kostenko, MD Principal Investigator
LLC X7 Clinical Research | St. Petersburg, 194156, Russian Federation Recruiting Dmitriy Nosovich Principal Investigator
Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center" | Ivano-Frankivs'k, 76025, Ukraine Recruiting Igor Vakaliuk, M.D., Ph.D Principal Investigator
Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department | Kharkiv, 61058, Ukraine Recruiting Igor Kyrychenko, M.D., Ph.D Principal Investigator
Scientific Medical Complex "University Clinic" of Kharkiv | Kharkiv, 61157, Ukraine Recruiting Nadiya Tryshchuk Principal Investigator
MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2 | Kharkiv, 61176, Ukraine Recruiting Vira Tseluyko, M.D., Ph.D Principal Investigator
Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council | Kryvyi Rih, 50031, Ukraine Recruiting Larysa Rudik, M.D. Principal Investigator
"Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City | Kyiv,, 01601, Ukraine Recruiting Liudmyla Alieksieieva, M.D. Principal Investigator
Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv | Kyiv, 01103, Ukraine Recruiting Oleksandr Bondarchuk, MD PhD Principal Investigator
Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv | Kyiv, 01601, Ukraine Recruiting Liudmyla Alieksieieva, M.D. Principal Investigator
Communal non-profit enterprise Kyiv City Clinical Hospital №1 | Kyiv, 02091, Ukraine Recruiting Oleksandr Karpenko, M.D., Ph.D Principal Investigator
Kyiv City Clinical Hospital of Emergency Aid, | Kyiv, 02166, Ukraine Recruiting Leonid Rudenko, M.D. Principal Investigator
Kyiv City Clinical Hospital of Emergency Aid | Kyiv, 02166, Ukraine Recruiting Leonid Rudenko, M.D. Principal Investigator
Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway" | Kyiv, 03049, Ukraine Recruiting Halyna Myshanych, M.D., Ph.D Principal Investigator
National Scientific Center Institute of Cardiology of M.D | Kyiv, 03680, Ukraine Recruiting Larysa Mishchenko, MD, PhD Principal Investigator
State Institution "National Scientific Center "Institute of Cardiology | Kyiv, 03680, Ukraine Recruiting Sergey Kozhukhov, MD, PhD Principal Investigator
Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL" | Kyiv, 04050, Ukraine Recruiting Oksana Reshotko, M.D. Principal Investigator
Medical Centre of LLC | Kyiv, 04050, Ukraine Recruiting Oksana Reshotko, M.D. Principal Investigator
MNPE "Lviv City Clinical Hospital No.5" | Lviv, 79000, Ukraine Recruiting Andriy Bazylevych, MD PhD Principal Investigator
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical | Lviv, 79041, Ukraine Recruiting Andriy Faynyk, M.D., Ph.D Principal Investigator
Vinnytsia Regional Clinical Hospital of Veterans of War | Vinnytsia, 21005, Ukraine Recruiting Valentyn Maslovskyi, M.D. Principal Investigator
"Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology" | Vinnytsia, 21029, Ukraine Recruiting Yuriy Mostovoy, MD, PhD, DM Principal Investigator
Communal Non-Profit Enterprise "City | Zaporizhzhia, 69001, Ukraine Recruiting Olexandr Palamarchuk, MD PhD Principal Investigator
Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine, | Zaporizhzhia, 69063, Ukraine Recruiting Mykhaylo Kolesnyk, M.D., Ph.D Principal Investigator
Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council, | Zaporizhzhia, 69600, Ukraine Recruiting Sergiy Dotsenko, MD Principal Investigator
Communal Enterprise "Hospital №1" of Zhytomyr City Council | Zhytomyr, 10002, Ukraine Recruiting Ivan Vyshnyvetskyy, M.D., Ph.D Principal Investigator
Location Countries

Australia

Bulgaria

Canada

Czechia

Georgia

Hungary

Latvia

Lithuania

New Zealand

Poland

Russian Federation

Ukraine

United States

Verification Date

2021-10-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ferric Carboxymaltose

Type: Active Comparator

Description: Ferric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by the results of iron indices.

Label: Placebo

Type: Placebo Comparator

Description: Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.

Acronym HEART-FID
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

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