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New pill aims to drain fluid in stubborn heart failure swelling

NCT ID NCT05615363

Symptom relief Sponsor: Otsuka Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called OPC-131461 in 157 people with congestive heart failure who still had fluid buildup despite taking standard water pills. Participants received different doses of the drug or a placebo daily for 14 days. The main goal was to see if the drug helped reduce body weight, a sign of fluid loss.

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 offer a new option to help heart failure patients shed excess fluid when standard diuretics aren't enough.
What could go wrong
This is an early Phase 2 trial with only 157 participants, so results may not hold up in larger studies. The drug may cause side effects or fail to improve symptoms meaningfully.

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.

Participants

157 people

The number who actually took part.

Started

Jan 2023

Finished

Oct 2024

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 to 89 years

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects with CHF with lower limb edema, pulmonary congestion, or jugular venous distension due to volume overload. * Subjects undergoing any of the following diuretic therapies * Loop diuretics at a dosage equivalent to 40 mg/day or more of furosemide tablet/fine granule * Concomitant administration of a loop diuretic and a thiazide diuretic (including similar drugs) at any doses * Concomitant administration of a loop diuretic and a mineralocorticoid receptor antagonist or potassium-sparing diuretic at any doses * Subjects who were currently hospitalized or who are able to be hospitalized Exclusion Criteria: * Subjects with acute heart failure * Subjects with an assisted circulation device * Subjects who cannot sense thirst or who have difficulty in ingesting water

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Conditions

The condition(s) this trial relates to.

congestive heart failure Edema, Cardiac heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac edema (CHF)

Contacts and locations

Locations

  • Harasanshin Hospital

    Fukuoka, Japan