Heart Failure Clinical Trials — A Patient's Guide

What is heart failure?

Heart failure does not mean the heart has stopped. It means the heart is not pumping or filling as well as it should, so the body does not get the blood and oxygen it needs. People with heart failure often notice shortness of breath, swelling in the legs or belly, fatigue, or trouble lying flat at night.

Doctors classify heart failure into a few distinct types, and the type matters because most clinical trials are designed for one specific group:

• HFrEF — Heart Failure with reduced Ejection Fraction. The pumping chamber of the heart is weakened. Ejection fraction (EF) is 40% or lower.
• HFpEF — Heart Failure with preserved Ejection Fraction. The heart pumps with a normal-looking EF (50% or higher), but it is stiff and does not fill properly.
• HFmrEF — Heart Failure with mildly reduced Ejection Fraction. EF sits in the 41-49% range, between HFrEF and HFpEF.
• Iron deficiency in heart failure — A separate concern that affects up to half of chronic heart failure patients, even when blood counts look normal. Some trials specifically enroll heart failure patients who also have iron deficiency.

Why this matters for trials: a trial designed for HFrEF will not enroll someone with HFpEF, and vice versa. The first thing the trial team checks is which type you have, usually using a recent echocardiogram.

If you are not sure which type you have, that is fine. The screening visit will confirm it. Bring any recent echo or cardiology notes if you have them.

What are heart failure trials testing in 2026?

Heart failure research has changed a lot in the last few years. The space is no longer just about diuretics and beta-blockers. Current trials are exploring several directions at once:

• New medications targeting non-traditional mechanisms. Examples include drugs that work on inflammation, fibrosis (scarring of the heart muscle), or the way the heart's own cells regenerate. These are different from older heart failure medicines and may help patients who are already on standard care.
• IV-administered therapies. Some investigational treatments are given as an infusion in the clinic rather than as a daily pill. These trials usually involve regular visits to a site with an infusion suite.
• Device-based therapies. New pacing strategies, structural-heart devices, and remote-monitoring sensors continue to be studied in heart failure populations.
• Iron-deficiency treatments. IV iron-replacement studies look at whether correcting iron deficiency in heart failure patients improves symptoms, exercise capacity, and outcomes — even in patients who are not anemic.
• HFpEF-specific approaches. HFpEF was historically much harder to treat than HFrEF. Several trials in 2026 are testing therapies designed specifically for the stiff-heart problem rather than the weak-heart problem.
• Combination therapies. Some trials look at adding a new drug on top of standard guideline-directed medical therapy to see whether the combination is better than current care alone.

A trial is not a guess. By the time a treatment reaches a Phase 2 or Phase 3 heart failure trial, it has already gone through earlier safety testing. The trial is asking a more specific question: does this work in real patients with heart failure, and is the risk reasonable for the potential benefit?

Who might be eligible?

Every heart failure trial has its own eligibility list. Some are narrow, some are broader. A few common requirements come up again and again:

• Documented heart failure — usually with an echocardiogram showing your ejection fraction, plus a clinical diagnosis from a cardiologist.
• Stable management on guideline-directed medical therapy — you are already on the standard heart failure medicines your cardiologist recommends, at stable doses for a defined period (often 4 weeks or more).
• NYHA Class II-III symptoms — meaning you have noticeable symptoms with everyday activity (Class II) or marked limitation with less-than-ordinary activity (Class III). Many trials exclude Class I (no symptoms) and Class IV (symptoms at rest).
• Specific lab values — kidney function, potassium, NT-proBNP, hemoglobin, ferritin, and other labs are often checked against trial-specific cutoffs.
• Age range — most trials enroll adults; some have an upper age limit.
• No recent hospitalization for heart failure — many trials require you to be clinically stable, often with no heart failure hospitalization in the past 30-90 days.
• Not pregnant or planning pregnancy during the study for relevant patients.

You may also be excluded for things like recent heart attack, active cancer treatment, severe kidney or liver disease, or being enrolled in another investigational study. None of these are personal — they are study-design decisions made to make the results clear and to keep participants safe.

The honest reality: most patients who screen for any given trial do not end up enrolling in that specific trial. If you are not eligible for one study, you may be eligible for another. We always check whether other current studies might fit.

What participation involves

Every heart failure trial is structured a little differently, but the general arc looks like this:

Screening (1-3 hours)

You meet the trial team. The Principal Investigator — a practicing cardiologist — reviews your history with you. You go through informed consent: a detailed document explaining what the trial is studying, what is involved, the known risks, and your right to leave at any time. You take as much time as you need. (For a section-by-section walkthrough, see our consent-form reading guide.) Basic measurements happen here: ECG, blood pressure, blood draw, sometimes an echocardiogram.

Baseline visit

If screening confirms eligibility, the baseline visit collects the starting measurements the trial uses to track change over time: NT-proBNP, echocardiogram, six-minute walk test, quality-of-life questionnaire (often the Kansas City Cardiomyopathy Questionnaire), and others depending on the protocol.

Treatment phase

This is the bulk of the trial. Visits typically happen every 1-3 months and last 1-3 hours. At each visit:

• The team reviews your symptoms and any side effects
• You may have an ECG, blood work, or other study tests
• You receive the study treatment if it is given on-site (such as an infusion)
• You return any unused study medication and get the next supply if it is a pill or injection you take at home
• You complete a symptom diary or app entry

Phone check-ins between visits are common.

End-of-study and follow-up

At the end of the treatment phase, you have a final visit with closing assessments. Many trials add a follow-up period (3, 6, or 12 months) where the site stays in touch to monitor longer-term outcomes. After that, you return to your regular cardiologist for ongoing care.

The total time commitment varies. A heart failure trial may run anywhere from a few months to two or three years. The consent form lays out the schedule before you sign anything.

What you might gain

Patients have different reasons for considering a trial. Common ones:

• Access to investigational treatments that are not yet available outside research.
• More frequent monitoring of your heart failure than routine care typically provides — additional ECGs, labs, and check-ins with a cardiology team.
• Possible symptom improvement for some participants, depending on which group you are randomized to and how the treatment performs.
• A meaningful contribution to research that may help future patients with heart failure.

We want to be honest here: a trial may help you, may not affect your symptoms, or in some cases may cause side effects. No one — not your cardiologist, not the trial team, not the sponsor — can promise benefit. That is exactly why the trial is being done: to find out.

What the risks are

Heart failure trials are highly regulated, but participation does carry real risks. Patients should know about:

• Side effects from the study treatment. These are listed in the consent form. Some are common, some rare, some serious.
• Randomization to a control group. In many trials, you are randomly assigned to receive either the new treatment or a placebo / standard care. You may not get the investigational treatment.
• Time commitment. Visits, labs, and study procedures take time and energy.
• Possible heart failure worsening. Heart failure can get worse over time on its own, and it is possible to experience a worsening during a trial. This is monitored very closely. Most heart failure trials use intensive safety monitoring through an independent Data Safety Monitoring Board (DSMB) that reviews trial data regularly and can pause or stop a trial early if patterns of concern appear.
• Inconvenience and travel. Trial visits are at the research site, not at your regular cardiology clinic.

You can withdraw at any time, for any reason, without it affecting your future medical care. You can also pause your participation if you have a hospitalization or another medical issue and resume later if eligible.

How to find out if you are eligible

There are three easy ways to start the conversation:

• Call (786) 703-5941. A 15-minute eligibility screening is free and does not commit you to anything.
• Use our patient contact form at /contact-patient.
• Have your cardiologist refer you. We coordinate with most Miami-area cardiology practices.

Bring or be ready to share: your most recent echocardiogram report, a list of your current medications (heart failure medicines and others), your most recent labs if available, and any heart failure hospitalizations in the past year.

Active heart failure trials at Amavita Research

We currently have heart failure protocols open at Amavita Research. As of the date on this page, two of them are:

• RENEU-HF (JK07) — a Phase 2 study of JK07, an investigational neuregulin-1 fusion protein for chronic heart failure, sponsored by Salubris Biotherapeutics.
• VS-041 (Pfizer Protocol VS-041-102) — an HFpEF-focused study sponsored by Pfizer.

For the current list of trials, eligibility detail, and contact information, see /therapeutic-areas/heart-failure. Trial availability changes — call us for the most current status.

Questions worth asking before you join

The trial team welcomes these questions. If yours is not on the list, ask anyway.

• What is the chance I will receive the investigational treatment versus placebo or control? This is set by the trial design and the team can tell you.
• If I am being evaluated for a heart transplant or LVAD, will joining this trial affect my candidacy? Some trials affect transplant evaluation timing; the team and your transplant center should align on this before you enroll.
• How will my regular cardiologist be kept in the loop? With your permission, we send updates and study data to your regular cardiology team so your care stays coordinated.
• What happens if my heart failure worsens during the study? The trial team manages it, may pause your participation, and your regular medical care continues as usual.
• Will I still need to see my regular cardiologist? Yes. The trial does not replace routine cardiology care.
• What happens at the end of the study? Can I keep the treatment? Sometimes, depending on the program. Ask about post-trial access if it matters to you.
• Are there any costs to me? For most cardiovascular trials at Amavita Research, study-related care is paid for by the sponsor. Routine medical care is still billed to your insurance as usual.

A note for caregivers

Heart failure affects the whole household. Caregivers — spouses, adult children, friends — are welcome at trial visits. Many patients bring someone to the screening and consent visit so a second set of ears hears the same information. We encourage that. Caregivers often think of practical questions the patient might not.

If your loved one has heart failure and is curious about a trial, you can also call us on their behalf to ask general questions. Patient-specific medical decisions of course remain with the patient.

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About the author: Amavita Research is a cardiovascular clinical trial site embedded inside amavita Heart and Vascular Health® in North Miami Beach, FL. Our PIs are practicing cardiologists. We see patients in English, Spanish, Haitian Creole, and Brazilian Portuguese. Call (786) 703-5941 or visit /contact-patient.