REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction (NCT06237309) | Clinical Trial Compass
TerminatedPhase 2
REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction
Stopped: Sponsor decision
United States, Belgium, Bulgaria89 participantsStarted 2024-04-11
Plain-language summary
This study is researching an experimental drug called REGN5381 (called "study drug"). The study is focused on patients with heart failure with reduced ejection fraction (ie, the heart is not functioning as well as it should).
The aim of the study is to see how safe, tolerable, and effective the study drug is.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Body mass index (BMI) between 18 and 45 kg/m\^2, inclusive, at initial screening visit
. Diagnosis of chronic heart failure
. Left ventricular ejection fraction 20-49% by echocardiogram performed within 3 months of screening
. Plasma NT-proBNP ≥800 pg/mL (or ≥1000 pg/mL if in atrial fibrillation) at screening (visit 1) and NT-proBNP ≥600 pg/mL (or ≥800 pg/mL if in atrial fibrillation) approximately 30 days prior to randomization (visit 5)
. Receiving optimized standard of care therapy for heart failure as described in the protocol
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in circulating N-Terminal pro-Brain Natriuretic Peptide (NTproBNP)
. eGFR of ≥30 mL/min/1.73 m2 according to locally used formula (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] preferred), at screening (visit 1) or approximately 30 days prior to randomization (visit 5) as described in the protocol
Exclusion criteria
. Hospital discharge within 180 days of anticipated randomization
. Resting SBP that remains out of range after two repeated measurements prior to randomization as described in the protocol
. Current or recent diagnosis of acute coronary syndrome or myocardial infarction as described in the protocol
. History of symptomatic autonomic dysfunction as evidenced by orthostatic hypotension and/or syncope
. Unexplained syncope \<12 months prior to initial screening or during the Run-in period
. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator that may confer unreasonable risk to the participant's participation in the study
. Uncorrected congenital heart disease
. Cardiac surgery within 6 months prior to screening or any planned surgery during the study