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New study tracks heart drug Vericiguat's safety in japanese patients

NCT ID NCT05666518

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This study follows 1,400 Japanese adults with chronic heart failure to see how safe the drug vericiguat is in everyday use. Half will take vericiguat plus standard care, the other half standard care alone. Researchers will track side effects, blood pressure, and heart-related deaths over two years. The goal is to gather real-world safety information, not to prove the drug works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vericiguat (Verquvo)
What this could lead to
If successful, this study could provide real-world safety data on vericiguat for Japanese patients with chronic heart failure, potentially supporting its broader use.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors other than the drug. It focuses on safety, not proving the drug works better than standard care.

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.

Participants

About 1,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

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.

Who is studied

The study population is composed of Japanese patients with chronic heart failure have been prescribed vericiguat or standard treatment by the physician.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: vericiguat arm: * Patients receiving standard treatment for chronic heart failure, and vericiguat will be treated in accordance with the package insert (no history of receiving vericiguat) * Patients who gave written consent to this investigation control arm: * Patients receiving standard treatment for chronic heart failure according to the package insert of vericiguat as following (no history of receiving vericiguat) * Prior (within 6 months) heart failure hospitalization or prior (within 3 months) intravenous (IV) diuretics for heart failure not requiring hospitalization (This will be applied only for the first \~75% of patients meeting this criteria to be enrolled.) Note: No more than approximately 25% of patients without a qualifying history of prior heart failure hospitalization within 6 months or prior IV diuretics for heart failure not requiring hospitalization within 3 months can be enrolled in the study. * New York Heart Association (NYHA) Classification: Class II to Class IV * Left ventricular ejection fraction (LVEF): less than 45% * Patients who gave written informed consent to this study Exclusion Criteria: vericiguat arm: \- Patients who are participating in an interventional study control arm: * Patients who have started or are scheduled to start therapy with vericiguat for chronic heart failure * Patients who are participating in an interventional study

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

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

Chronic heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Japanese registries

    RECRUITING

    Multiple Locations, Many Locations, Japan

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