Heart failure drug trial pulled before it even started
NCT ID NCT06795399
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study was designed to test an experimental drug called OPC-131461 in people hospitalized for worsening heart failure who still had fluid buildup after standard treatment. The goal was to see if the drug could improve a key blood marker of heart strain over 30 days. However, the trial was withdrawn before any participants were enrolled, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OPC-131461
- What this could lead to
- If it works, this could point toward a new oral treatment to help heart failure patients recover faster and reduce rehospitalization.
- What could go wrong
- The trial was withdrawn before enrolling any participants, so no data exists. Even if tested, early-phase results often fail to translate into real-world benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
-
Apr 2025
- Finished
-
May 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of HF ≥ 3 months prior to screening. * Admitted to the hospital with primary diagnosis of WHF and received treatment with intravenous (IV) diuretics. * Eligible participants will be randomized no earlier than 48 hours and up to 5 days after presentation to the hospital as long as they meet the following definition of stable status: Stable for at least 24 hours, defined by systolic blood pressure (SBP) ≥ 90 millimeters of mercury (mmHg) for preceding 24 hours, no increase in diuretic dose for 24 hours prior to randomization, did not receive IV inotropic or vasodilator (including nitrates) for 24 hours prior to randomization, and no oxygen therapy or mechanical ventilation in the 24 hours prior to randomization * Left ventricular ejection fraction (LVEF) assessed either during hospitalization for Index Event or within 12 months prior to randomization. * Has evidence of incomplete decongestion, indicated by NT-proBNP levels \> 750 picograms per milliliter (pg/mL) (or \> 1000 pg/mL if in atrial fibrillation). At hospital sites where NT proBNP test is unavailable at screening: B-type natriuretic peptide (BNP) \> 375 pg/mL (or \> 500 pg/mL if in atrial fibrillation). Exclusion Criteria: * Primary cause of WHF (Index Event) due to valvular heart disease (defined as severe aortic or primary mitral regurgitation, moderate or severe aortic stenosis, any mitral stenosis requiring surgical repair, or active endocarditis), congenital heart disease, hypertrophic obstructive cardiomyopathy, pulmonary embolism, Type I myocardial infarction, infection, severe anemia, exacerbation of chronic obstructive pulmonary disease (COPD), or sustained ventricular tachycardia, or bradycardia with sustained ventricular rate \< 45 beats/minute. * Duration of hospitalization for Index Event \> 2 weeks at time of screening. * End-stage HF requiring at the time of screening left ventricular assist device (LVAD), intra-aortic balloon pump (IABP) or any similar mechanical support. * Cardiac surgery (coronary artery bypass grafting \[CABG\]), percutaneous coronary intervention (PCI), implantation of a cardiac device or cardiac mechanical support implantation within 30 days prior to randomization or planned during the study * Severely impaired renal function eGFR \< 25 milliliters per minute per 1.73-meter square (mL/min/1.73m\^2). * History of dialysis or kidney transplant. * History of cirrhosis or noncirrhotic portal hypertension. * Severe hyponatremia Sodium (Na) level \< 125 mEq/L (milliequivalents per liter) or hypernatremia Na level \> 145 mEq/L). * Systolic blood pressure \< 90 mmHg at screening. * History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies. * History of any significant drug allergy or known or suspected hypersensitivity to any component of the study drug. * Use of any investigational drug within 30 days prior to screening. * History of serious mental disorders that, in the opinion of the investigator, would exclude the participant from participating in this trial. Note: Other protocol-specified inclusion and exclusion criteria may apply.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Heart failure are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an inhaler boost heart pumping in COPD patients?
- Can zapping the heart beat drugs for AF in heart failure?
- Which SGLT2 inhibitor wins? trial pits empagliflozin against dapagliflozin
- Can daily mindful breathing ease heart failure symptoms?
- Can a smartphone app keep heart failure patients out of the hospital?
- Can better training get doctors to talk about what matters most to dying veterans?