Clinical Trials

Explore our ongoing clinical trials that aim to advance medical research and improve patient care. 

Trials Open to Enrollment


A PREliminary Study for the Intervention of an N-of-1 protocol FOR MEDication optimization (PRE-INFORMED)

PRE-INFORMED aims to determine whether N-of-1 trials, a pragmatic, patient-centered approach to medication optimization that can overcome key barriers of deprescribing, can lead to increased patient confidence regarding the decision to continue or discontinue beta-blockers in older adults with Heart Failure with Preserved Ejection Fraction (HFpEF).

Research Coordinator: Princess Osma -

Status: Enrolling 

N-of-1 for Beta-Blockers in Cardiac Amyloidosis

N-of-1 Trials to Promote Deprescribing in Older Adults With Transthyretin Cardiac Amyloidosis

The goal of this study is to generate preliminary data on whether patients with cardiac amyloidosis feel better when their beta-blocker is stopped. To achieve this objective, 20 N-of-1 trials (on vs. off) will be conducted, and the study team will subsequently interview participants to better understand their outcomes. We will also engage stakeholders to understand the acceptability and feasibility of deprescribing N-of-1 trials.

Research Coordinator: Princess Osma -

Status: Enrolling 


Physical Rehabilitation for Older Patients With Acute Heart Failure With Preserved Ejection 

REHAB-HFpEF is a multicenter, randomized, attention-controlled, single-blind trial that aims to determine whether the REHAB-HF intervention, compared with attention control usual care, will reduce the primary endpoint of combined all-cause rehospitalizations and all-cause mortality in older patients hospitalized with acute decompensated HFpEF at 6 months follow-up.

Research Coordinator: Alexandra Reich -

Status: Enrolling


Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults (PREVENTABLE)

PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.

Research Coordinator: Fernando Park -

Status: Enrolling


A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation (HERMES)

HERMES is a multi-center, randomized study aims to examine whether ziltivekimab can be used to treat people living with heart failure and inflammation, through participants receiving either ziltivekimab or a placebo. Participants will have to use a study application on their phone to record and share information about all their injections of study medicine and to fill in questionnaires. 

Research Coordinator: Joseph Lohmann -

Status: Enrolling


Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction (EF) Heart Failure

This is a multicenter, prospective, randomized, sham controlled, double blinded clinical trial, that aims to test the efficacy of a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and Corvia Atrial Shunt implant procedure versus a control. The primary endpoint is a composite of heart failure event rates and Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months.

Research Coordinator: Nadine Alkouchiri -

Status: Enrolling 


LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)

LEVEL is a phase 3, double-blind, randomized, placebo controlled study to evaluate the efficacy of TNX-103 (levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).

Research Coordinator: Caroline Goldstein -

Status: Enrolling 


Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (AURORA-HFpEF)

AURORA-HFpEF is a Phase 2A, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF).

Research Coordinator: Nadine Alkouchiri -

Status: Enrolling

Trials Closed to Enrollment


Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF (REBALANCE-HF)

REBALANCE-HF aimed to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in patients with heart failure with preserved ejection fraction (HFpEF).

HuMAIN Study

Exploratory Phase 2A, Double-blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety, Tolerability, PD, and PK of HU6 for the Treatment of Subjects With Obese Heart Failure With Preserved Ejection Fraction (HFpEF)

HuMAIN aimed to determine the safety, tolerability, pharmacodynamics, and pharmacokinetics of HU6 for the treatment of subjects with Obese Heart Failure with Preserved Ejection Fraction (HFpEF). Subjects were randomized (1:1) either to HU6 or placebo. 


A Study of Mavacamten in Participants With HFpEF and Chronic Elevation of cTnI and/or NT-proBNP (EMBARK-HFpEF)

EMBARK-HFpEF evaluated the effect of mavacamten treatment on biomarkers levels in participants with heart failure with preserved ejection fraction (HFpEF) and chronic elevation of cTnI and/or NT-proBNP. 


A Study to Evaluate the Efficacy and Safety of AKCEA-TTR-LRx in Participants With Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

CARDIO-TTransform evaluated the efficacy of AKCEA-TTR-LRx compared to placebo for 120 weeks in patients with ATTR-CM receiving available standard of care (SoC).

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Pilot Deprescribing N-of-1 Trials for Beta-blockers in HFpEF

N-of-1 Trials for Deprescribing Beta-blockers in HFpEF

This study tested the feasibility of N-of-1 trials for deprescribing beta-blockers in patients with Heart Failure with Preserved Ejection Fraction. To achieve this objective, we conducted 4-period N-of-1 trials (on vs. off) and subsequently interviewed participants to better understand feasibility and pragmatism. 


INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart

INVESTED tested the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. 


A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients with Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease

SERENADE evaluated whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease. The primary objective was to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.


Dapagliflozin Evaluation to Improve the LIVEs of Patients with Preserved Ejection Fraction

DELIVER was an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, which evaluated the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.


The ToRsemide compArisoN with furoSemide FOR Management of HF

TRANSFORM-HF was a large-scale, pragmatic, randomized, unblinded clinical effectiveness study comparing torsemide versus furosemide as treatment for heart failure. The primary objective of the TRANSFORM-HF study was to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who were hospitalized.


STEP-HFpEF: Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

STEP-HFpEF investigated how well semaglutide works in people living with obesity and heart failure. This study evaluated how the participants daily life was affected by their heart failure and the change in participants body weight from the start to the end of the study, to compare the effect on heart failure symptoms and body weight in people taking semaglutide versus the placebo. 

Weill Cornell Medicine
The Program for the Care and Study of the Aging Heart

1305 York Ave, 8th floor
New York, NY 10021
Phone: (646) 962-7571
Fax: (212) 746-6665