Ablazione endovascolare del grande nervo splancnico destro in soggetti con HFpEF (Rebalance-HF)
ABLAZIONE ENDOVASCOLARE DEL GRANDE NERVO SPLANCNICO DESTRO IN Ablazione endovascolare del grande nervo splancnico destro in soggetti con HFpEF: studio di fattibilità: studio di fattibilità controllato randomizzato- studio di riequilibrio dell'HF
The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve. The study includes people who have heart failure with preserved ejection fraction (HFpEF). The goal is to learn whether this procedure, performed using the Satera Ablation System, may help improve symptoms and to better understand which patients may benefit most from this treatment in the future.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Up to 150 people will take part in this clinical study.
Phase I of the REBALANCE-HF Study
The first part of the study took place between January 2021 and March 2023. During this phase, 116 patients participated. Researchers reviewed the results to learn whether the procedure appeared safe and whether it might help improve symptoms in people with heart failure with preserved ejection fraction (HFpEF).
This early review showed encouraging results in some patients. It also helped researchers identify a group of patients who seemed more likely to benefit from the procedure.
Phase II of the REBALANCE-HF Study:
The current phase of the study focuses on patients who have similar characteristics to those who responded well in Phase I. The goal is to confirm whether this group of patients may benefit most from the treatment and whether the procedure should be studied further in a larger future trial.
This study will take place at multiple hospitals and research centers.
Participants who qualify for the study will be randomly assigned to one of two groups:
- Treatment group: The procedure is performed using the Satera Ablation System to treat a nerve called the greater splanchnic nerve.
- Control (sham) group: A simulated procedure is performed, but the treatment itself is not delivered.
Participants will be assigned to a group by chance, similar to flipping a coin, although twice as many patients will receive the treatment as the sham procedure (2:1 ratio).
The group assignment will happen during the procedure after anesthesia is given, and only after the doctor confirms that the patient's anatomy is suitable for the procedure.
Blinding:
To make sure the results are fair and unbiased:
- Participants and their heart failure doctors will not know whether the patient received the treatment or the sham procedure.
- The doctor performing the procedure and certain study staff will know which procedure is performed so they can carry out the procedure safely.
- The study safety team will also know this information to help monitor patient safety.
Sham Procedure:
A sham procedure is used to help researchers understand whether any improvements are due to the treatment itself or to the placebo effect.
During the sham procedure:
A small needle puncture is made in the groin or neck, similar to what is done for many heart procedures.
Doctors check the veins to confirm whether the procedure could have been performed.
However, the treatment catheter is not used and the nerve is not treated.
The sham procedure takes about 45 minutes, which is about the same amount of time as the treatment procedure.
Number of Participants:
90 patients were assigned to treatment or sham during Phase I.
In Phase II, up to 60 additional patients will be enrolled.
About 40 patients will receive the treatment, and about 20 will receive the sham procedure.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Judit Adorjan
- Numero di telefono: 16507221119
- Email: j.adorjan@axontherapies.com
Backup dei contatti dello studio
- Nome: Desiree McFee, MS
- Numero di telefono: 6123568881
- Email: desiree@axontherapies.com
Luoghi di studio
-
-
-
Tbilisi, Georgia
- Reclutamento
- Tbilisi Heart and Vascular Center
-
Investigatore principale:
- Tamaz Shaburishvili, MD
-
Contatto:
- Teona Zirakashvili
- Email: zirakashvilit@gmail.com
-
Tbilisi, Georgia
- Attivo, non reclutante
- Tbilisi Heart Center
-
-
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti, 35211
- Completato
- Cardiology PC
-
-
Arizona
-
Phoenix, Arizona, Stati Uniti, 85016
- Completato
- Arizona Cardiovascular Research Center
-
-
California
-
La Jolla, California, Stati Uniti, 92037
- Reclutamento
- Scripps Health
-
Investigatore principale:
- Rajeev Mohan, MD
-
Investigatore principale:
- Matthew Price, MD
-
Contatto:
- Stefania Marzano
- Email: marzano.stefania@scrippshealth.org
-
San Francisco, California, Stati Uniti, 94143
- Reclutamento
- University of California, San Francisco
-
Investigatore principale:
- Liviu Klein, MD
-
Contatto:
- Priscilla Zhang
- Numero di telefono: 415-514-7903
- Email: Priscilla.Zhang@ucsf.edu
-
San Francisco, California, Stati Uniti, 94143
- Reclutamento
- Zuckerberg San Francisco General Hospital and Trauma Center
-
Contatto:
- Kathrine (Kati) Steineman
- Numero di telefono: 707-718-3130
- Email: katherine.steineman@ucsf.edu
-
Investigatore principale:
- Lucas ZIer, MD
-
-
Georgia
-
Augusta, Georgia, Stati Uniti, 30901
- Non ancora reclutamento
- Piedmont
-
Investigatore principale:
- Darshak Karia, MD
-
Contatto:
- Jennifer Hansen, RN
- Numero di telefono: 706-724-2463
- Email: Jennifer.Hansen@piedmont.org
-
Contatto:
- Kimberly Allen, RN
- Numero di telefono: 706-945-6961
- Email: kimberly.allen3@piedmont.org
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60611
- Reclutamento
- Bluhm Cardiovascular Institute of Northwestern University
-
Investigatore principale:
- Ravi Patel, MD
-
Contatto:
- Daniel Roshevsky
- Email: droshevs@nm.org
-
Chicago, Illinois, Stati Uniti, 60637
- Reclutamento
- University of Chicago Medical Center
-
Contatto:
- Adaeze Emeka
- Email: adaeze.emeka@bsd.uchicago.edu
-
Investigatore principale:
- Mark Nathan Belkin, MD
-
Contatto:
- Nai Qashou
- Email: nai.qashou@bsd.uchicago.edu
-
Springfield, Illinois, Stati Uniti, 62701
- Completato
- Prairie Education and Research Cooperative
-
-
Indiana
-
Indianapolis, Indiana, Stati Uniti, 46260
- Completato
- Ascension St. Vincent - Cardiovascular Research Institute
-
-
Louisiana
-
Houma, Louisiana, Stati Uniti, 70360
- Reclutamento
- Cardiovascular Institute of the South
-
Investigatore principale:
- Peter Fail, MD
-
Contatto:
- Kimberly Lirette
- Email: kimberly.lirette@cardio.com
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48109
- Reclutamento
- Michigan Medicine, University of Michigan
-
Investigatore principale:
- Scott Hummel, MD
-
Contatto:
- Nikita Sawant Dessai
- Email: dessai@med.umich.edu
-
-
Minnesota
-
Rochester, Minnesota, Stati Uniti, 55905
- Reclutamento
- Mayo Clinic
-
Investigatore principale:
- Barry Borlaug, MD
-
Contatto:
- Annabelle Fuemffinger
- Numero di telefono: 507-422-3801
- Email: Fuenffinger.Annabelle@mayo.edu
-
-
Missouri
-
St Louis, Missouri, Stati Uniti, 63136
- Reclutamento
- St. Louis Heart and Vascular
-
Investigatore principale:
- Gil Vardi, MD
-
Contatto:
- Melissa McCann
- Email: mmccann@slhv.com
-
-
New York
-
New York, New York, Stati Uniti, 10021
- Reclutamento
- Weill Cornell Medicine
-
Investigatore principale:
- Parag Goyal, MD
-
Contatto:
- Sara Kirschner
- Email: ski4008@med.cornell.edu
-
New York, New York, Stati Uniti, 10032
- Reclutamento
- Columbia University Medical Center
-
Investigatore principale:
- Nir Uriel, MD
-
Contatto:
- Benita Cui
- Email: bc3329@cumc.columbia.edu
-
New York, New York, Stati Uniti, 10029
- Completato
- Icahn School of Medicine at Mount Sinai
-
Rochester, New York, Stati Uniti, 14621
- Reclutamento
- Rochester General Hospital
-
Contatto:
- Kathleen Ebeling, RN
- Email: kathleen.ebeling@rochesterregional.org
-
Investigatore principale:
- Vishal Parikh, DO
-
-
North Carolina
-
Durham, North Carolina, Stati Uniti, 27710
- Reclutamento
- Duke University Medical Center
-
Investigatore principale:
- Marat Fudim, MD, MHS
-
Contatto:
- Matthew Gray
- Email: james.gray@duke.edu
-
-
Ohio
-
Cincinnati, Ohio, Stati Uniti, 45219
- Non ancora reclutamento
- The Christ Hospital
-
Investigatore principale:
- Odayme Quesada, MD
-
Contatto:
- Shelby Johnson
- Numero di telefono: 513-585-4849
- Email: Shelby.Johnson@thechristhospital.com
-
Columbus, Ohio, Stati Uniti, 43210
- Reclutamento
- Ohio State University Wexner Medical Center
-
Investigatore principale:
- Alexandria Miller, MD
-
Contatto:
- Halle Woodruff
- Email: halle.woodruff@osumc.edu
-
-
South Carolina
-
Charleston, South Carolina, Stati Uniti, 29425
- Reclutamento
- Medical University of South Carolina
-
Investigatore principale:
- Sheldon Litwin, MD
-
Contatto:
- Elly Borhanian
- Email: borhania@musc.edu
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Reclutamento
- Baylor College of Medicine
-
Investigatore principale:
- Ajith Nair, MD
-
Contatto:
- Claudell Montano
- Numero di telefono: 713-798-6832
- Email: claudell.montano@bcm.edu
-
-
Virginia
-
Richmond, Virginia, Stati Uniti, 23298
- Completato
- Virginia Commonwealth University Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria
-
Chronic heart failure, defined as:
- Symptoms of HF requiring current (intermittent or continuous) treatment with diuretics for >30 days, AND
- NYHA class II with a history of >NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening or signs of HF (any rales post cough, chest x-ray demonstrating pulmonary congestion), AND
- At least one of the following:
i. ≥1 HF hospital admission (with HF as the primary diagnosis) including treatment with intravenous (IV) diuretics or urgent unplanned treatment with IV diuretics in healthcare facility within past 12 months, OR ii. NT-proBNP >300 pg/ml in normal sinus rhythm (>450 pg/ml in atrial fibrillation or flutter) within the past 6 months; BNP >100 pg/ml in normal sinus rhythm (>300 pg/ml in atrial fibrillation or flutter) within the past 6 months, OR iii. Right heart catheterization (RHC) with PCWP ≥ with PCWP ≥18 mmHg at rest or 25 mmHg during exercise at the time of the screening RHC.
-
Ongoing stable GDMT HF management (unless unable to tolerate GDMT) and management of potential comorbidities according to the 2022 ACCF/AHA Guideline for the Management of Heart Failure (Class 1 and 2a recommendations), with no significant changes [≥100% increase or ≥50% decrease] for a minimum of 1 month (30 days) prior to screening, that is expected to be maintained without change for at least 6 months. Participants cannot have started a glucagon-like peptide (GLP)-1 or gastric inhibitory peptide (GIP) agonist within the last 6 months or plan to start a GLP-1 or GIP agonist within the ensuing 6 months after enrollment.
-
LVEF ≥50% (site-determined by transthoracic echocardiography) within the past 6 months.
-
Age ≥40 years.
-
Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
Exclusion Criteria:
-
MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization.
-
Cardiac resynchronization therapy initiated within 3 months prior to screening.
-
Advanced heart failure defined as one or more of the following:
- ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.
- Inotropic infusion (continuous or intermittent) within 6 months prior to screening.
- Subject is on the cardiac transplant waiting list.
- Presence of or prior history of mechanical circulatory support for HF.
-
Poor left heart compliance as determined by pulse-wave Doppler transmitral early-to-late (E/A) ratio >2.0 assessed by the screening echocardiogram. The Screening Committee will evaluate left heart function if the transmitral A velocity is not measurable or absent.
-
Right heart dysfunction defined as tricuspid annular plane systolic excursion (TAPSE) <12 mm or right ventricular (RV) fractional area change (FAC) <25% assessed by the screening echocardiogram.
-
Body mass index (BMI) >45 kg/m2.
-
6-minute walk test distance <100 meters OR >450 meters.
-
Admission for HF within the 30 days prior to planned index procedure.
-
Any known history of orthostatic hypotension or orthostatic hypotension at the time of screening (regardless of the presence of symptoms). Orthostatic hypotension is defined as a systolic blood pressure (BP) decrease of >20 mmHg upon going from supine to standing position or undergoing treatment with Midodrine.
-
Orthostatic pulse pressure change from supine to standing decrease of >10mmHg in the absence of a HR increase >15bpm
-
Postural orthostatic tachycardia syndrome or preload insufficiency syndrome.
-
Systolic BP <100 mmHg or >170 mmHg despite appropriate medical management.
-
Baseline screening ECG resting HR >100 beats per minute or ventricular tachycardia.
-
Catheter ablation for atrial fibrillation within 6 months prior to screening or planned in the next 12 months at the time of screening.
-
Left ventricular EF <40% within the 3 years prior to screening unless reduced EF was transient and associated with an acute event.
-
Presence of significant valve disease defined by the site cardiologist as:
- Greater than mild mitral valve stenosis.
- Greater than moderate mitral valve regurgitation.
- Greater than moderate-to-severe tricuspid valve regurgitation.
- Greater than moderate aortic valve stenosis or regurgitation.
-
Known hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).
-
History of clinically significant liver cirrhosis.
-
Prior weight loss surgery
-
Dialysis dependent; or estimated GFR <25 ml/min/1.73 m2 by CKD-EPI creatinine equation.
-
Arterial oxygen saturation <90% on room air.
-
Chronic pulmonary disease requiring continuous home oxygen OR hospitalization for exacerbation of chronic pulmonary disease (including intubation) in the 12 months before study entry OR known history of GOLD Class III or worse chronic obstructive pulmonary disease (COPD).
-
Participating in conflicting investigational drug or device study that is not completed within 30 days prior to the screening visit.
-
Life expectancy <12 months for non-cardiovascular reasons.
-
Any condition, or history of illness or surgery that, in the opinion of the site investigator or Screening Committee, might confound the results of the study or pose additional risks to the patient.
-
Females who are pregnant or lactating or planning to become pregnant during the next year.
-
Any of the following measured by screening right heart catheterization:
- Mean right atrial pressure (RAP) >20 mmHg at rest
- Cardiac index <2.0 L/min/m2 at rest
- Pulmonary vascular resistance (PVR) >4 Wood units
Exclusion Criteria Assessed During the index procedure:
-
Vessel tortuosity or variant vascular anatomy that could preclude the access or maneuvering of the interventional device from the access site to target vessel. This includes previous spine surgery that may impact the ability to access and treat the target sites of T11 and T10.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Comparatore attivo: Greater Splanchnic Nerve Ablation
After anesthesia is given, doctors will use the Satera Ablation System to reach a nerve called the right greater splanchnic nerve. Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve. |
The greater splanchnic nerve (GSN) ablation procedure begins with a small needle puncture in the groin or neck to access a vein, using methods that are commonly used for heart procedures. Doctors then guide thin tubes and wires through the vein to reach a nerve called the right greater splanchnic nerve. X-ray imaging is used to help the doctor see where the catheter is and guide it to the correct location. Once the catheter is in the right place, the doctor uses the device to treat the nerve using controlled heat. |
|
Comparatore fittizio: Sham Control Arm
After anesthesia is given, doctors will place a small tube into a vein. The steps and length of the procedure will be similar to the Axon treatment procedure, but the study treatment will not be performed. |
During the sham procedure, a small needle puncture will be made in the groin or neck to access a vein using standard medical techniques. A short tube will be placed into the vein, similar to what is done for many heart procedures. The Satera catheter and treatment devices will not be inserted, and the nerve will not be treated. The procedure will take about the same amount of time as the treatment procedure. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Primary Safety Endpoint: Device or procedure related serious adverse events
Lasso di tempo: 1 Month
|
Evaluation of device or procedure-related serious adverse events at 1-month follow-up based on Clinical Events Committee (CEC) assessment |
1 Month
|
|
Primary Efficacy Endpoint: KCCQ (6 months)
Lasso di tempo: Baseline through 6-months
|
Assessment of change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6-month follow up visit |
Baseline through 6-months
|
|
Primary Efficacy Endpoint: 6MWT (6 months)
Lasso di tempo: Baseline through 6 months
|
Assessment of change in Six Minute Walk Test (6MWT) from baseline to the 6-month follow up visit |
Baseline through 6 months
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pulmonary Capillary Wedge Pressure (PCWP)
Lasso di tempo: Baseline through 1-month
|
Change in pulmonary capillary wedge pressure (PCWP) at resting, legs up, 20 Watts, and Peak Exercise Stage from Baseline to the 1-month follow up visit |
Baseline through 1-month
|
|
Stress blood volume
Lasso di tempo: Baseline through 1-month
|
Change in estimated stress blood volume at resting, legs up, 20Watts, and Peak Exercise Stage from Baseline to the 1-month follow up visit. |
Baseline through 1-month
|
|
NT-proBNP
Lasso di tempo: Baseline through 24-months
|
Change in NT-proBNP levels from Baseline through the 24-month visit |
Baseline through 24-months
|
|
KCCQ (24-months)
Lasso di tempo: Baseline through 24-months
|
Change in KCCQ scores from baseline through the 24-month visit |
Baseline through 24-months
|
|
6MWT (24-months)
Lasso di tempo: Baseline through 24-months
|
Change in 6MWT from Baseline through the 24-month visit |
Baseline through 24-months
|
|
Time to first heart failure event
Lasso di tempo: Treatment through 24-months
|
Time to first heart failure event (hospitalizations and worsening heart failure events) through the 24-month visit |
Treatment through 24-months
|
|
Incidence of heart failure events
Lasso di tempo: Treatment through 24-months
|
Incidence of heart failure events (hospitalizations and worsening heart failure events) through the 24-month visit |
Treatment through 24-months
|
|
Hierarchical composite endpoint (12-months)
Lasso di tempo: Baseline through 12-months
|
Composite endpoint of cardiovascular death, heart failure events, and changes in KCCQ from Baseline to the 12-month visit |
Baseline through 12-months
|
|
Incidence of serious device related cardiac or vascular events
Lasso di tempo: Treatment through 12- and 24-months
|
Assessment of the incidence of serious device related cardiac or vascular events through 12- and 24-months |
Treatment through 12- and 24-months
|
|
Device or procedure related pain
Lasso di tempo: Treatment through 24-months
|
Assessment of device or procedure related pain lasting at least 30 days and requiring medical management |
Treatment through 24-months
|
|
Orthostatic hypotension
Lasso di tempo: Treatment through 12- and 24-months
|
Incidence of new orthostatic hypotension up to 12- and 24-months |
Treatment through 12- and 24-months
|
|
Acute Kidney Injury (AKI)
Lasso di tempo: Baseline through 12-and 24-months
|
Incidence of AKI requiring renal replacement therapy up to 12- and 24-months |
Baseline through 12-and 24-months
|
|
Glomerular Filtration Rate (GFR)
Lasso di tempo: Baseline through 12- and 24-months
|
Incidence of worsening GFR (defined as >50% for at least 30 days in duration) up to 12- and 24-months |
Baseline through 12- and 24-months
|
|
Adverse Events
Lasso di tempo: Procedure through 12- and 24-months
|
Incidence of all Adverse Events through 12- and 24-months |
Procedure through 12- and 24-months
|
|
Mortality
Lasso di tempo: Procedure through 6-, 12- and 24-months
|
Incidence of all mortality for up to 6-, 12-, and 24-months summarized as all-cause mortality, CV mortality, or heart failure-related |
Procedure through 6-, 12- and 24-months
|
Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Exploratory endpoint: Heart failure related medication changes (24-months)
Lasso di tempo: Baseline through 24-months
|
Freedom from heart failure related medication changes through the 24-month visit |
Baseline through 24-months
|
|
Exploratory Endpoint: Diuretic medication (24-months)
Lasso di tempo: Baseline through 24-months
|
Change in diuretic dose through the 24-month visit |
Baseline through 24-months
|
|
Exploratory Endpoint: Diastolic function (24-months)
Lasso di tempo: Baseline through 24-months
|
Assessment of diastolic function by transthoracic echocardiography evaluated over time from baseline through 24-months |
Baseline through 24-months
|
|
Exploratory Endpoint: C-reactive protein
Lasso di tempo: Baseline through 24-months
|
Change in c-reactive protein levels from Baseline through 24-months |
Baseline through 24-months
|
|
Exploratory Endpoint: Aldosterone (ALD)
Lasso di tempo: Baseline through 24-months
|
Change in aldosterone levels from Baseline through 24-months |
Baseline through 24-months
|
|
Exploratory Endpoint: Renin
Lasso di tempo: Baseline through 24-months
|
Change in Renin levels from Baseline through 24-months |
Baseline through 24-months
|
|
Exploratory Endpoint: Weight
Lasso di tempo: Baseline through 24-months
|
Change in weight from Baseline through 24-months |
Baseline through 24-months
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Sanjiv S Shah, MD, Northwestern University
Pubblicazioni e link utili
Pubblicazioni generali
- Gheorghiade M, Vaduganathan M, Fonarow GC, Bonow RO. Rehospitalization for heart failure: problems and perspectives. J Am Coll Cardiol. 2013 Jan 29;61(4):391-403. doi: 10.1016/j.jacc.2012.09.038. Epub 2012 Dec 5.
- Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
- Lam CS, Donal E, Kraigher-Krainer E, Vasan RS. Epidemiology and clinical course of heart failure with preserved ejection fraction. Eur J Heart Fail. 2011 Jan;13(1):18-28. doi: 10.1093/eurjhf/hfq121. Epub 2010 Aug 3.
- Finkelstein DM, Schoenfeld DA. Combining mortality and longitudinal measures in clinical trials. Stat Med. 1999 Jun 15;18(11):1341-54. doi: 10.1002/(sici)1097-0258(19990615)18:113.0.co;2-7.
- Ezekowitz JA, O'Meara E, McDonald MA, Abrams H, Chan M, Ducharme A, Giannetti N, Grzeslo A, Hamilton PG, Heckman GA, Howlett JG, Koshman SL, Lepage S, McKelvie RS, Moe GW, Rajda M, Swiggum E, Virani SA, Zieroth S, Al-Hesayen A, Cohen-Solal A, D'Astous M, De S, Estrella-Holder E, Fremes S, Green L, Haddad H, Harkness K, Hernandez AF, Kouz S, LeBlanc MH, Masoudi FA, Ross HJ, Roussin A, Sussex B. 2017 Comprehensive Update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure. Can J Cardiol. 2017 Nov;33(11):1342-1433. doi: 10.1016/j.cjca.2017.08.022. Epub 2017 Sep 6.
- Borlaug BA, Nishimura RA, Sorajja P, Lam CS, Redfield MM. Exercise hemodynamics enhance diagnosis of early heart failure with preserved ejection fraction. Circ Heart Fail. 2010 Sep;3(5):588-95. doi: 10.1161/CIRCHEARTFAILURE.109.930701. Epub 2010 Jun 11.
- Chaudhry SI, Wang Y, Concato J, Gill TM, Krumholz HM. Patterns of weight change preceding hospitalization for heart failure. Circulation. 2007 Oct 2;116(14):1549-54. doi: 10.1161/CIRCULATIONAHA.107.690768. Epub 2007 Sep 10.
- Ziaeian B, Fonarow GC. Epidemiology and aetiology of heart failure. Nat Rev Cardiol. 2016 Jun;13(6):368-78. doi: 10.1038/nrcardio.2016.25. Epub 2016 Mar 3.
- Adamson PB, Magalski A, Braunschweig F, Bohm M, Reynolds D, Steinhaus D, Luby A, Linde C, Ryden L, Cremers B, Takle T, Bennett T. Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an implantable monitoring system. J Am Coll Cardiol. 2003 Feb 19;41(4):565-71. doi: 10.1016/s0735-1097(02)02896-6.
- Zile MR, Bennett TD, St John Sutton M, Cho YK, Adamson PB, Aaron MF, Aranda JM Jr, Abraham WT, Smart FW, Stevenson LW, Kueffer FJ, Bourge RC. Transition from chronic compensated to acute decompensated heart failure: pathophysiological insights obtained from continuous monitoring of intracardiac pressures. Circulation. 2008 Sep 30;118(14):1433-41. doi: 10.1161/CIRCULATIONAHA.108.783910. Epub 2008 Sep 15.
- Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025. Epub 2017 Apr 28. No abstract available.
- Shah KS, Xu H, Matsouaka RA, Bhatt DL, Heidenreich PA, Hernandez AF, Devore AD, Yancy CW, Fonarow GC. Heart Failure With Preserved, Borderline, and Reduced Ejection Fraction: 5-Year Outcomes. J Am Coll Cardiol. 2017 Nov 14;70(20):2476-2486. doi: 10.1016/j.jacc.2017.08.074. Epub 2017 Nov 12.
- Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.
- Steinberg BA, Zhao X, Heidenreich PA, Peterson ED, Bhatt DL, Cannon CP, Hernandez AF, Fonarow GC; Get With the Guidelines Scientific Advisory Committee and Investigators. Trends in patients hospitalized with heart failure and preserved left ventricular ejection fraction: prevalence, therapies, and outcomes. Circulation. 2012 Jul 3;126(1):65-75. doi: 10.1161/CIRCULATIONAHA.111.080770. Epub 2012 May 21.
- McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
- Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available.
- Fudim M, Fail PS, Litwin SE, Shaburishvili T, Goyal P, Hummel SL, Borlaug BA, Mohan RC, Patel RB, Mitter SS, Klein L, Rocha-Singh K, Patel MR, Reddy VY, Burkhoff D, Shah SJ. Endovascular ablation of the right greater splanchnic nerve in heart failure with preserved ejection fraction: early results of the REBALANCE-HF trial roll-in cohort. Eur J Heart Fail. 2022 Aug;24(8):1410-1414. doi: 10.1002/ejhf.2559. Epub 2022 May 29.
- Fudim M, Patel MR, Boortz-Marx R, Borlaug BA, DeVore AD, Ganesh A, Green CL, Lopes RD, Mentz RJ, Patel CB, Rogers JG, Felker GM, Hernandez AF, Sunagawa K, Burkhoff D. Splanchnic Nerve Block Mediated Changes in Stressed Blood Volume in Heart Failure. JACC Heart Fail. 2021 Apr;9(4):293-300. doi: 10.1016/j.jchf.2020.12.006. Epub 2021 Mar 10.
- Malek F, Gajewski P, Zymlinski R, Janczak D, Chabowski M, Fudim M, Martinca T, Neuzil P, Biegus J, Mates M, Kruger A, Skalsky I, Bapna A, Engelman ZJ, Ponikowski PP. Surgical ablation of the right greater splanchnic nerve for the treatment of heart failure with preserved ejection fraction: first-in-human clinical trial. Eur J Heart Fail. 2021 Jul;23(7):1134-1143. doi: 10.1002/ejhf.2209. Epub 2021 Jul 16.
- Maher JW, Johlin FC, Pearson D. Thoracoscopic splanchnicectomy for chronic pancreatitis pain. Surgery. 1996 Oct;120(4):603-9; discussion 609-10. doi: 10.1016/s0039-6060(96)80006-7.
- Fudim M, Boortz-Marx RL, Ganesh A, DeVore AD, Patel CB, Rogers JG, Coburn A, Johnson I, Paul A, Coyne BJ, Rao SV, Gutierrez JA, Kiefer TL, Kong DF, Green CL, Jones WS, Felker GM, Hernandez AF, Patel MR. Splanchnic Nerve Block for Chronic Heart Failure. JACC Heart Fail. 2020 Sep;8(9):742-752. doi: 10.1016/j.jchf.2020.04.010. Epub 2020 Jun 10.
- Fudim M, Jones WS, Boortz-Marx RL, Ganesh A, Green CL, Hernandez AF, Patel MR. Splanchnic Nerve Block for Acute Heart Failure. Circulation. 2018 Aug 28;138(9):951-953. doi: 10.1161/CIRCULATIONAHA.118.035260. No abstract available.
- Baghdadi S, Abbas MH, Albouz F, Ammori BJ. Systematic review of the role of thoracoscopic splanchnicectomy in palliating the pain of patients with chronic pancreatitis. Surg Endosc. 2008 Mar;22(3):580-8. doi: 10.1007/s00464-007-9730-x. Epub 2007 Dec 28.
- RAPAPORT E, WEISBART MH, LEVINE M. The splanchnic blood volume in congestive heart failure. Circulation. 1958 Oct;18(4 Part 1):581-7. doi: 10.1161/01.cir.18.4.581. No abstract available.
- Burkhoff D, Tyberg JV. Why does pulmonary venous pressure rise after onset of LV dysfunction: a theoretical analysis. Am J Physiol. 1993 Nov;265(5 Pt 2):H1819-28. doi: 10.1152/ajpheart.1993.265.5.H1819.
- Funakoshi K, Hosokawa K, Kishi T, Ide T, Sunagawa K. Striking volume intolerance is induced by mimicking arterial baroreflex failure in normal left ventricular function. J Card Fail. 2014 Jan;20(1):53-9. doi: 10.1016/j.cardfail.2013.11.007. Epub 2013 Nov 28.
- Barnes RJ, Bower EA, Rink TJ. Haemodynamic responses to stimulation of the splanchnic and cardiac sympathetic nerves in the anaesthetized cat. J Physiol. 1986 Sep;378:417-36. doi: 10.1113/jphysiol.1986.sp016228.
- Fudim M, Ganesh A, Green C, Jones WS, Blazing MA, DeVore AD, Felker GM, Kiefer TL, Kong DF, Boortz-Marx RL, Hernandez AF, Patel MR. Splanchnic nerve block for decompensated chronic heart failure: splanchnic-HF. Eur Heart J. 2018 Dec 21;39(48):4255-4256. doi: 10.1093/eurheartj/ehy682. No abstract available.
- Brooksby GA, Donald DE. Dynamic changes in splanchnic blood flow and blood volume in dogs during activation of sympathetic nerves. Circ Res. 1971 Sep;29(3):227-38. doi: 10.1161/01.res.29.3.227. No abstract available.
- Greenway CV. Role of splanchnic venous system in overall cardiovascular homeostasis. Fed Proc. 1983 Apr;42(6):1678-84.
- CHIEN S. Cell volume, plasma volume and cell percentage in splanchnic circulation of splenectomized dogs. Circ Res. 1963 Jan;12:22-8. doi: 10.1161/01.res.12.1.22. No abstract available.
- DELORME EJ, MacPHERSON AI, MUKHERJEE SR, ROWLANDS S. Measurement of the visceral blood volume in dogs. Q J Exp Physiol Cogn Med Sci. 1951;36(4):219-31. doi: 10.1113/expphysiol.1951.sp000975. No abstract available.
- Greenway CV, Lister GE. Capacitance effects and blood reservoir function in the splanchnic vascular bed during non-hypotensive haemorrhage and blood volume expansion in anaesthetized cats. J Physiol. 1974 Mar;237(2):279-94. doi: 10.1113/jphysiol.1974.sp010482.
- Gelman S. Venous function and central venous pressure: a physiologic story. Anesthesiology. 2008 Apr;108(4):735-48. doi: 10.1097/ALN.0b013e3181672607.
- Fudim M, Kaye DM, Borlaug BA, Shah SJ, Rich S, Kapur NK, Costanzo MR, Brener MI, Sunagawa K, Burkhoff D. Venous Tone and Stressed Blood Volume in Heart Failure: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 May 10;79(18):1858-1869. doi: 10.1016/j.jacc.2022.02.050.
- Sorimachi H, Burkhoff D, Verbrugge FH, Omote K, Obokata M, Reddy YNV, Takahashi N, Sunagawa K, Borlaug BA. Obesity, venous capacitance, and venous compliance in heart failure with preserved ejection fraction. Eur J Heart Fail. 2021 Oct;23(10):1648-1658. doi: 10.1002/ejhf.2254. Epub 2021 Jun 17.
- Fudim M, Hernandez AF, Felker GM. Role of Volume Redistribution in the Congestion of Heart Failure. J Am Heart Assoc. 2017 Aug 17;6(8):e006817. doi: 10.1161/JAHA.117.006817. No abstract available.
- Fallick C, Sobotka PA, Dunlap ME. Sympathetically mediated changes in capacitance: redistribution of the venous reservoir as a cause of decompensation. Circ Heart Fail. 2011 Sep;4(5):669-75. doi: 10.1161/CIRCHEARTFAILURE.111.961789. No abstract available.
- Dickstein K, Vardas PE, Auricchio A, Daubert JC, Linde C, McMurray J, Ponikowski P, Priori SG, Sutton R, van Veldhuisen DJ; ESC Committee for Practice Guidelines. 2010 Focused Update of ESC Guidelines on device therapy in heart failure: an update of the 2008 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC Guidelines for cardiac and resynchronization therapy. Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association. Europace. 2010 Nov;12(11):1526-36. doi: 10.1093/europace/euq392. No abstract available.
- Metra M, Faggiano P, D'Aloia A, Nodari S, Gualeni A, Raccagni D, Dei Cas L. Use of cardiopulmonary exercise testing with hemodynamic monitoring in the prognostic assessment of ambulatory patients with chronic heart failure. J Am Coll Cardiol. 1999 Mar 15;33(4):943-50. doi: 10.1016/s0735-1097(98)00672-x.
- Zile MR, Bennett TD, El Hajj S, Kueffer FJ, Baicu CF, Abraham WT, Bourge RC, Warner Stevenson L. Intracardiac Pressures Measured Using an Implantable Hemodynamic Monitor: Relationship to Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2017 Jan;10(1):e003594. doi: 10.1161/CIRCHEARTFAILURE.116.003594.
- Butler J, Filippatos G, Jamal Siddiqi T, Brueckmann M, Bohm M, Chopra VK, Pedro Ferreira J, Januzzi JL, Kaul S, Pina IL, Ponikowski P, Shah SJ, Senni M, Vedin O, Verma S, Peil B, Pocock SJ, Zannad F, Packer M, Anker SD. Empagliflozin, Health Status, and Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial. Circulation. 2022 Jan 18;145(3):184-193. doi: 10.1161/CIRCULATIONAHA.121.057812. Epub 2021 Nov 15.
- Fudim M, Borlaug BA, Mohan RC, Price MJ, Fail P, Goyal P, Hummel SL, Zirakashvili T, Shaburishvili T, Patel RB, Reddy VY, Nielsen CD, Chetcuti SJ, Sukul D, Gulati R, Kim L, Benzuly K, Mitter SS, Klein L, Uriel N, Augostini RS, Blair JE, Rocha-Singh K, Burkhoff D, Patel MR, Somo SI, Litwin SE, Shah SJ. Endovascular Ablation of the Greater Splanchnic Nerve in Heart Failure With Preserved Ejection Fraction: The REBALANCE-HF Randomized Clinical Trial. JAMA Cardiol. 2024 Dec 1;9(12):1143-1153. doi: 10.1001/jamacardio.2024.2612.
- Fudim M, Litwin SE, Borlaug BA, Mohan RC, Price MJ, Fail P, Zirakashvili T, Shaburishvili T, Goyal P, Hummel SL, Patel RB, Reddy VY, Burkhoff D, Patel MR, Somo SI, Shah SJ. Endovascular Ablation of the Right Greater Splanchnic Nerve in Heart Failure With Preserved Ejection Fraction: Rationale, Design and Lead-in Phase Results of the REBALANCE-HF Trial. J Card Fail. 2024 Jul;30(7):877-889. doi: 10.1016/j.cardfail.2023.12.010. Epub 2024 Jan 9.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 09868
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .