Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency (HEART-FID)

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Iron-deficiency
• Intervention / Treatment: Drug: Ferric Carboxymaltose; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 3065
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital
  • Macquarie Park, Australia, 2109
    • Macquarie University - Clinical Trials Unit
  • New Lambton Heights, Australia, 2305
    • John Hunter Hospital
  • Richmond, Australia, 3121
    • Epworth HealthCare Clinical Trials
  • New South Wales
    • Liverpool, New South Wales, Australia, 1871
      • SWSLHD-Liverpool Hospital
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Hospital
    • Cairns, Queensland, Australia, 4870
      • Cairns Hospital
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
    • Milton, Queensland, Australia, 4064
      • Core Research Group
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
    • Ashford, South Australia, Australia, 5035
      • SA Heart
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
    • Elizabeth Vale, South Australia, Australia, 5112
      • Lyell McEwin Hospital
  • Sydney
    • Darlinghurst, Sydney, Australia
      • Heart Lung Clinic
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • MHAT Puls
  • Gabrovo, Bulgaria, 5300
    • Multiprofile Hospital for Active Treatment: Department of cardiology
  • Haskovo, Bulgaria, 6304
    • MHAT Haskovo AD
  • Lom, Bulgaria, 3600
    • Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology
  • Pleven, Bulgaria, 5800
    • Medical Center Medconsult Pleven Ood
  • Sevlievo, Bulgaria, 5400
    • МC Hipokrena
  • Sofia, Bulgaria, 1113
    • Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology
  • Sofia, Bulgaria, 1202
    • Second Medical Center-Sofia, EEOD - Department of Cardiology
  • Sofia, Bulgaria, 1202
    • Second Multiprofile Hospital for Active Treatment
  • Sofia, Bulgaria, 1233
    • 5th City Hospital
  • Sofia, Bulgaria, 1233
    • National Multiprofile Transport Hospital Cardiology Clinic
  • Sofia, Bulgaria, 1510
    • Medical Center Hera EOOD - Office of Cardiology
  • Veliko Tarnovo, Bulgaria, 5002
    • Multiprofile Regional Hospital for Active Treatment
  • Velingrad, Bulgaria, 4600
    • Medical Center Velingrad 2017" EOOD, Office of Cardiology
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calbary
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
    • Edmonton, Alberta, Canada, T6L 6K3
      • South Edmonton Cardiology Consultants
    • Edmonton, Alberta, Canada
      • Royal Alexandria Hospital
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Fraser Clinical Trials
    • Surrey, British Columbia, Canada, V3V 0C6
      • SMH Cardiology Clinical Trials
    • Vancouver, British Columbia, Canada, V6E 1M7
      • St. Paul's Hospital
    • Victoria, British Columbia, Canada, V8R 4R2
      • Victoria Heart Institute Foundation
  • New Brunswick
    • Moncton, New Brunswick, Canada
      • G.A. Research Associates, Ltd.
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Health Sciences Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Nova Scotia Health Authority
  • Ontario
    • Burlington, Ontario, Canada, L7R 1A4
      • Manna Research Inc., Burlington South
    • Cambridge, Ontario, Canada, N1R 6V6
      • Cambridge Cardiac Care Center
    • Cambridge, Ontario, Canada, N1R 7R1
      • Vizel Cardiac Research
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Center (LHSC)
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5G 1X5
      • Sinai Health System - Mount Sinai Hospital
  • Quebec
    • Lévis, Quebec, Canada, G6V 4Z5
      • Clinique de Cardiologie de Levis
    • Montréal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre (MUHC)
    • Québec, Quebec, Canada, G1V 4G5
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
    • Saint-Georges, Quebec, Canada, G5Y 4T8
      • CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges
    • Saint-Jérôme, Quebec, Canada, J7Z 5T3
      • Recherche Medical St-Jerome Inc.
    • Trois-Rivières, Quebec, Canada, G8Z 3R9
      • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• Czechia
  • Brno, Czechia, 625 00
    • Interni kardiologicka klinika FN Brno
  • Chlumec Nad Cidlinou, Czechia, 50353
    • Kardiologicka ambulance
  • Prague, Czechia, 128 08
    • Centrum preventivní kardiologie, Karlovo nám. 32,
  • Prague, Czechia, 128 08
    • Centrum preventivní kardiologie
  • Prague, Czechia, 128 08
    • General University Hospital in Prague
  • Prague, Czechia, 128 08
    • General University Hospital
  • Prague, Czechia, 140 21
    • IKEM-Klinika kardiologie
• Georgia
  • Batumi, Georgia, 6010
    • JSC Evex Hospitals,Georgia
  • Kutaisi, Georgia, 4600
    • Clinic-LJ
  • Tbilisi, Georgia, 0159
    • Bokhua Memorial Cardiovascular Center
  • Tbilisi, Georgia, 0159
    • Tbilisi Heart and Vascular Clinic
  • Tbilisi, Georgia, 0102
    • Aleksandre Aladashvili Clinic LLC
  • Tbilisi, Georgia, 0112
    • Ltd Israel-Georgian Medical Research Clinic "Helsicore"
  • Tbilisi, Georgia, 0114
    • Ltd Pineo Medical Ecosistem
  • Tbilisi, Georgia, 0159
    • Acad. G. Chapidze Emergency Cardiology Center
  • Tbilisi, Georgia, 0160
    • Ltd TIM- Tbilisi Institute of Medicine
  • Tbilisi, Georgia, 0172
    • Georgian-Dutch Hospital
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Központ Kardiológiai Osztály
  • Gyöngyös, Hungary, 3200
    • Clinexpert Gyöngyös Kft
  • Harkány, Hungary, 7815
    • Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház
  • Kecskemet, Hungary, 6000
    • Bács-Kiskun Megyei Kórház Kardiológiai Osztály
  • Miskolc, Hungary, 3529
    • Andrea Hornyik, MD
  • Pecs, Hungary, 7624
    • Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika,
  • Szolnok, Hungary, 5000
    • Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály
  • Zalaegerszeg, Hungary, 8900
    • Belvarosi Egeszseghaz Kft
• Latvia
  • Daugavpils, Latvia, LV5417
    • Daugavpils Regional Hospital
  • Liepaja, Latvia, LV3414
    • Liepajas Regional Hospital
  • Riga, Latvia, LV1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV1038
    • Riga East University hospital clinic Gailezers
• Lithuania
  • Kaunas, Lithuania, 50161
    • The Hospital of Lithuanian
  • Klaipėda, Lithuania, 92288
    • Klaipeda Seaman's Hospital
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Klinikos
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Auckland, New Zealand, 2025
    • Middlemore Hospital
  • Auckland, New Zealand, 0622
    • North Shore Hospital
  • Auckland, New Zealand, 0600
    • Totara Clinical Research, Health New Lynn
  • Christchurch, New Zealand, 8140
    • Christchurch Heart Institute
  • Dunedin, New Zealand, 9016
    • Dunedin Hospital
  • Gisborne, New Zealand, 4010
    • Hauora Tairāwhiti Department of Cardiology
  • Hastings, New Zealand, 4120
    • Hawke's Bay Hospital
  • Lower Hutt, New Zealand, 5010
    • Hutt Hospital
  • Nelson, New Zealand, 7010
    • Nelson Hospital
  • New Plymouth, New Zealand, 4310
    • Taranaki Base Hospital
  • Rotorua, New Zealand
    • Rotorua Hospital
  • Tauranga, New Zealand, 3112
    • Clinical Horizons NEW ZEALAND LTD
  • Wellington
    • Newton, Wellington, New Zealand, 6021
      • Wellington Hospital
• Poland
  • Bytom, Poland, 41-902
    • Oddział Kardiologii WSzS nr 4
  • Józefów, Poland, 05-410
    • Biokinetica S.A. Przychodnia Józefów
  • Kraków, Poland, 30-394
    • Centrum Medyczne Linden
  • Lublin, Poland, 20-049
    • 1 Wojskowy Szpital Klininiczny w Lublinie
  • Lublin, Poland, 20-362
    • KO-MED Centra Kliniczne
  • Miechów, Poland, 32-200
    • Szpital Swietej Anny w Miechowie
  • Nowy Dwór Mazowiecki, Poland, 05-100
    • Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna
  • Oława, Poland, 55-200
    • Zespol Opieki Zdrowotnej
  • Toruń, Poland, 87-100
    • Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej
  • Warszawa, Poland, 02-097
    • Uniwersyteckie Centrum Kliniczne
  • Wołomin, Poland, 05-200
    • Centrum Medyczne K2J2
  • Wrocław, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • Wrocław, Poland, 50-981
    • 4th Military Hospital
  • Wrocław, Poland, 53-428
    • Proximum Centrum Usług Medycznych NZOZ
  • Łódź, Poland, 94-048
    • Marcin Ogórek, MD, PhD
• Russian Federation
  • Chelyabinsk, Russian Federation, 454017
    • Municipal Autonomous Healthcare Institution "City Clinical Hospital #6
  • Chelyabinsk, Russian Federation, 454017
    • Municipal Autonomous Healthcare Institution
  • Kemerovo, Russian Federation, 650002
    • Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
  • Moscow, Russian Federation, 117292
    • State Budgetary Healthcare Institution of Moscow city "Moscow
  • Pushkin, Russian Federation, 196603
    • Private Medical Institution "Euromedservice
  • Ryazan, Russian Federation, 390026
    • State Budgetary Institution of Ryazan Region
  • Saint Petersburg, Russian Federation, 190013
    • JSC Polyclinic Complex
  • Saint Petersburg, Russian Federation, 195257
    • Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital"
  • Saint Petersburg, Russian Federation, 196143
    • LLC "Scientific Research Center Eco-Safety"
  • Saint-Petersburg, Russian Federation, 190013
    • JSC Polyclinic Complex
  • Saratov, Russian Federation, 410002
    • State Healthcare Institution
  • Saratov, Russian Federation, 410054
    • Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia
  • St. Petersburg, Russian Federation, 192242
    • Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze
  • St. Petersburg, Russian Federation, 192242
    • Saint Petersburg Research Institute of Emergency Medicine
  • St. Petersburg, Russian Federation, 194156
    • LLC X7 Clinical Research
• Ukraine
  • Ivano-Frankivs'k, Ukraine, 76025
    • Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center"
  • Kharkiv, Ukraine, 61058
    • Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department
  • Kharkiv, Ukraine, 61157
    • Scientific Medical Complex "University Clinic" of Kharkiv
  • Kharkiv, Ukraine, 61176
    • MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2
  • Kryvyi Rih, Ukraine, 50031
    • Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council
  • Kyiv, Ukraine, 01103
    • Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv
  • Kyiv, Ukraine, 01601
    • Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv
  • Kyiv, Ukraine, 02091
    • Communal non-profit enterprise Kyiv City Clinical Hospital №1
  • Kyiv, Ukraine, 02166
    • Kyiv City Clinical Hospital of Emergency Aid,
  • Kyiv, Ukraine, 02166
    • Kyiv City Clinical Hospital of Emergency Aid
  • Kyiv, Ukraine, 03049
    • Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway"
  • Kyiv, Ukraine, 03680
    • National Scientific Center Institute of Cardiology of M.D
  • Kyiv, Ukraine, 03680
    • State Institution "National Scientific Center "Institute of Cardiology
  • Kyiv, Ukraine, 04050
    • Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL"
  • Kyiv, Ukraine, 04050
    • Medical Centre of LLC
  • Kyiv,, Ukraine, 01601
    • "Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City
  • Lviv, Ukraine, 79000
    • MNPE "Lviv City Clinical Hospital No.5"
  • Lviv, Ukraine, 79041
    • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical
  • Vinnytsia, Ukraine, 21005
    • Vinnytsia Regional Clinical Hospital of Veterans of War
  • Vinnytsia, Ukraine, 21029
    • "Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology"
  • Zaporizhzhia, Ukraine, 69001
    • Communal Non-Profit Enterprise "City
  • Zaporizhzhia, Ukraine, 69063
    • Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine,
  • Zaporizhzhia, Ukraine, 69600
    • Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
  • Zhytomyr, Ukraine, 10002
    • Communal Enterprise "Hospital №1" of Zhytomyr City Council
• United States
  • Alabama
    • Alexander City, Alabama, United States, 35010
      • Advanced Cardiovascular LLC
    • Auburn, Alabama, United States, 36830
      • Advanced Cardiovascular, LLC
    • Mobile, Alabama, United States, 36617
      • University of South Alabama
    • Mobile, Alabama, United States, 36604
      • IMC/Diagnostic & Medical Clinic
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Heart & Vascular Institute
  • Arizona
    • Cottonwood, Arizona, United States, 86326
      • Verde Valley Medical Center
    • Surprise, Arizona, United States, 85374
      • Clinical Research Institute of Arizona, LLC
    • Tucson, Arizona, United States, 85710
      • Carondelet Heart and Vascular Institute - Cardiology East
  • Arkansas
    • Fort Smith, Arkansas, United States, 72901
      • Sparks Regional Medical Center
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Beverly Hills, California, United States, 90211
      • Westside Medical Associates of Los Angeles
    • Carson, California, United States, 90509
      • Harbor-UCLA Medical Center
    • Covina, California, United States, 91723
      • Valley Clinical Trials, Inc.
    • El Cajon, California, United States, 92020
      • TriWest Research Associates, LLC
    • Huntington Beach, California, United States, 92648
      • California Heart Specialists
    • Lancaster, California, United States, 93534
      • First Valley Medical Group
    • Long Beach, California, United States, 90806
      • Healthcare Partners Affiliation Medical Group
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Mission Viejo, California, United States, 92691
      • St. Joseph Heritage-Healthcare
    • Newport Beach, California, United States, 92663
      • Radin Cardiovascular Medical Group, Inc.
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Pasadena, California, United States, 91105
      • Pasadena Clinical Research
    • Port Hueneme, California, United States, 93041
      • Eugene Soroka, MD Inc.
    • San Diego, California, United States, 92161
      • VA San Diego Health Care System
    • West Hills, California, United States, 91307
      • Interventional Cardiology Medical Group
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates, PC
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Hospital
    • Stamford, Connecticut, United States, 06904
      • Stamford Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care
    • Wilmington, Delaware, United States, 19803
      • Alfieri Cardiology
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Cardiology Associates of South Florida
    • Bradenton, Florida, United States, 34209
      • Cardiovascular & Vein Center of Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research Of West Florida, Inc.
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
    • Jacksonville, Florida, United States, 32209
      • Uf Health Jacksonville
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Healthcare - Riverside
    • Jacksonville, Florida, United States, 32216
      • St. Vincent's Healthcare - Southside Recruiting
    • Miami, Florida, United States, 33165
      • Med-Care Research
    • Miami, Florida, United States, 33176
      • Vista Health Research
    • Miami, Florida, United States, 33130
      • ProLive Medical Research
    • Miami, Florida, United States, 33155
      • Cordova Research Institute, LLC
    • Miami, Florida, United States, 33173
      • ITB Research
    • Miami Lakes, Florida, United States, 33016
      • Empire Clinical Research, LLC
    • Orlando, Florida, United States, 32804
      • Florida Hospital Transplant Institute
    • Palm Beach Gardens, Florida, United States, 33410
      • Cardiology Partners Clinical Research Institute
    • Panama City, Florida, United States, 32401
      • Springfield Medical Center
    • Pembroke Pines, Florida, United States, 33024
      • Broward Research Center
    • Pembroke Pines, Florida, United States, 33026
      • South Florida Research Solutions, LLC
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research Center
    • Pensacola, Florida, United States, 32501
      • Cardiology Consultants
    • Saint Petersburg, Florida, United States, 33713
      • Professional Health Care of Pinellas
    • Vero Beach, Florida, United States, 32960
      • Indian River Medical Center
    • Wellington, Florida, United States, 33449
      • Cardiology Partners Clinical Research Institute
  • Georgia
    • Athens, Georgia, United States, 30606
      • Piedmont Heart Institute - Athens
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Augusta, Georgia, United States, 30901
      • University Cardiology Associates, LLC
    • Fayetteville, Georgia, United States, 30214
      • Piedmont Heart Institute Fayetteville
    • Macon, Georgia, United States, 31201
      • Georgia Arrhythmia Consultants and Research Institute
    • Macon, Georgia, United States, 31201
      • Mercer University
    • Smyrna, Georgia, United States, 30082
      • Atlanta Vanguard Research Institute
  • Idaho
    • Boise, Idaho, United States, 83712
      • Saint Luke's Boise Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Mount Sinai Hospital Medical Center - Department of Cardiology
    • Fairview Heights, Illinois, United States, 62208
      • Medicoricium, LLC
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Physician Network - Indiana Heart Physicians
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Medical Group
    • Muncie, Indiana, United States, 47303
      • Indiana University Health Ball Memorial Hospital, Inc.
    • Richmond, Indiana, United States, 47374
      • Reid Physician Associates / Reid Health
    • South Bend, Indiana, United States, 46601
      • Beacon Medical Group Advanced Cardiovascular Specialists
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Alexandria Cardiology Clinic
    • Hammond, Louisiana, United States, 70403
      • Heart Clinic of Hammond
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health System
    • New Orleans, Louisiana, United States, 70112
      • Tulane Heart & Vascular Institute
    • Slidell, Louisiana, United States, 70458
      • Louisiana Heart Center
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Partners Maine Health Cardiology
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Health System Research Institute
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Fall River, Massachusetts, United States, 02721
      • NECCR Prima Care Research, LLC
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center
    • Kalamazoo, Michigan, United States, 49008
      • Western Michigan University Homer Stryker M.D. School of Medicine
    • Saginaw, Michigan, United States, 48602
      • Michigan CardioVascular Institute at Covenant Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Allina Health System, dba Abbott Northwestern Hospital
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates Research, LLC
  • Missouri
    • North Kansas City, Missouri, United States, 64116
      • North Kansas City Hospital
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart & Vascular, PC
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
    • Omaha, Nebraska, United States, 68124
      • CHI Health Research Center
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University Medical Center of Southern Nevada
    • Las Vegas, Nevada, United States, 89146
      • Red Rock Clinical Research, LLC
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Monmouth Cardiology Associates, LLC
    • Englewood, New Jersey, United States, 07631
      • Englewood Health
    • Flemington, New Jersey, United States, 08822
      • Advanced Heart & Vascular Institute of Hunterdon
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
    • Newark, New Jersey, United States, 07102
      • Saint Michael's Medical Center
    • Newark, New Jersey, United States, 07103
      • Rutgers New Jersey Medical School
    • Pomona, New Jersey, United States, 08240
      • AtlantiCare Regional Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
    • Somerset, New Jersey, United States, 08873
      • Cardio Metabolic Institute
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Presbyterian Brooklyn Methodist Hospital
    • Cheektowaga, New York, United States, 14227
      • Trinity Medical WNY, PC
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
    • Staten Island, New York, United States, 10310
      • Richmond University Medical Center
    • Stony Brook, New York, United States, 11794-7007
      • Stony Brook University Hospital
    • West Seneca, New York, United States, 14224
      • Circuit Clinical
    • Williamsville, New York, United States, 14221
      • Northtowns Cardiology, PLLC
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Cardiology Associates
    • Durham, North Carolina, United States, 27710
      • Duke University Heart Failure Research
    • Greensboro, North Carolina, United States, 27401
      • Medication Management, LLC
    • High Point, North Carolina, United States, 27262
      • Wake Forest University Health Sciences
    • Lumberton, North Carolina, United States, 28358
      • Duke Cardiology of Lumberton
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Mooresville, North Carolina, United States, 28117
      • Crossroads Clinical Research, Inc.
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Medical Clinic, Inc.
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Health and Hospitals
    • Raleigh, North Carolina, United States, 27607
      • NC Heart & Vascular Research
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • North Dakota
    • Minot, North Dakota, United States, 58701
      • Trinity Health Center - Medical Arts
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Cardiology Clinical Trials
    • Cleveland, Ohio, United States, 44109
      • The MetroHealth System
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Elyria, Ohio, United States, 44035
      • North Ohio Heart Center
    • Sandusky, Ohio, United States, 44870
      • North Ohio Heart Center
    • Springfield, Ohio, United States, 45505
      • Heart House Research Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • South Oklahoma Heart Research, LLC
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Camp Hill, Pennsylvania, United States, 17011
      • Penn State Health Holy Spirit Medical Center Geisinger - Cardiology
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania - Perelman Center for Advanced Medicine
    • Pittsburgh, Pennsylvania, United States, 15240
      • V.A. Pittsburgh Healthcare System
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prisma Health
    • Greenwood, South Carolina, United States, 29646
      • Self Regional Hospital Research Center
    • Lancaster, South Carolina, United States, 29720
      • Carolina Heart Specialists
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc.
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular Foundation
    • Knoxville, Tennessee, United States, 37934
      • Tennova Healthcare-Turkey Creek Medical Center
    • Oak Ridge, Tennessee, United States, 37830
      • Parkway Cardiology Associates, PC
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Hearth Clinical Research Institute, Inc.
    • Amarillo, Texas, United States, 79106
      • PharmaTex Research
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • Dallas, Texas, United States, 75231
      • Cardiovascular Research Institute of Dallas
    • Dallas, Texas, United States, 75235
      • Southwest Family Medicine Associates
    • Fort Worth, Texas, United States, 76104
      • Texas Health Research & Education Institute
    • Houston, Texas, United States, 77030
      • Texas Heart Institute
    • Kingwood, Texas, United States, 77339
      • Houston Heart & Vascular Associates
    • Lubbock, Texas, United States, 79410
      • Caprock Cardiac Center Research Institute, Inc.
    • Lufkin, Texas, United States, 75904
      • Angelina Medical Research, LLC
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates
    • McKinney, Texas, United States, 75701
      • North Texas Research Associates
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants, PLLC
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Medical Center
    • Tyler, Texas, United States, 75708
      • The University of Texas Health Center at Tyler
    • Tyler, Texas, United States, 75701
      • PharmaTex Research
    • Wichita Falls, Texas, United States, 76301
      • Wichita Falls Heart Clinic
  • Utah
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research/Intermountain Heart Center PC
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The University of Vermont Medical Center
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Stroobants Cardiovascular Center
    • Newport News, Virginia, United States, 23601
      • Riverside Cardiology Specialists
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23298
      • VCU Medical Center
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J)
    • Roanoke, Virginia, United States, 24014
      • Carilion Medical Center
    • Winchester, Virginia, United States, 22601
      • Selma Medical Associates
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
    • Seattle, Washington, United States, 98122
      • Swedish Heart & Vascular-Advanced Cardiac Support Program
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center & Children's Hospital
    • Tacoma, Washington, United States, 98405
      • CHI Franciscan Research Center
    • Walla Walla, Washington, United States, 99362
      • Walla Walla Clinic
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital & Clinics
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • ProHealth Care Inc / Waukesha Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ferric Carboxymaltose; 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.	Drug: Ferric Carboxymaltose; Intravenous Iron; Other Names: Injectafer, Ferinject
Placebo Comparator: Placebo; Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.	Drug: Placebo; Normal Saline Solution; Other Names: Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of death	1 year
Incidence of hospitalization for heart failure	1 year
Change in 6MWT distance	6 months

Collaborators and Investigators

• Sponsor: American Regent, Inc.
• Collaborators: Duke Clinical Research Institute
• Investigators: Study Chair: Adrian F Hernandez, MD, Duke Clinical Research Institute

Publications and helpful links

General Publications

• Mentz RJ, Ambrosy AP, Ezekowitz JA, Lewis GD, Butler J, Wong YW, De Pasquale CG, Troughton RW, O'Meara E, Rockhold FW, Garg J, Samsky MD, Leloudis D, Dugan M, Mundy LM, Hernandez AF; HEART-FID Trial Investigators. Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and Design. Circ Heart Fail. 2021 May;14(5):e008100. doi: 10.1161/CIRCHEARTFAILURE.120.008100. Epub 2021 May 18.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Heart Failure; Anemia, Iron-Deficiency
• Other Study ID Numbers: 1VIT15043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No