Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart failure drug combo shows promise for leaky valve patients

NCT ID NCT05991284

Disease control Sponsor: Ziekenhuis Oost-Limburg 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding sacubitril-valsartan to standard care helps people with heart failure (with preserved pumping ability) and a leaky mitral valve. 84 participants were randomly assigned to get the drug or standard care alone. Researchers measured heart function and exercise capacity after six months to see if the drug improves blood flow and symptoms.

What this could mean

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

Active substance
sacubitril-valsartan
What this could lead to
If it works, this could improve heart function and exercise capacity in patients with a specific type of heart failure and leaky mitral valve.
What could go wrong
This is a small, completed phase 4 trial with 84 participants. The results may not apply to all heart failure patients, and the drug may cause side effects like low blood pressure or kidney issues.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

84 people

The number who actually took part.

Started

Feb 2024

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 95 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: * Age \> 18 years. * New York Heart Association class II to IV. * Written informed consent. * Left ventricular (LV) ejection fraction ≥ 50%. * Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides. * ≥ moderate functional MR assessed by transthoracic echocardiography within the previous year. Exclusion Criteria: * Systolic blood pressure \< 100 mmHg. * Potassium ≥ 5.2 mmol/L. * Estimated Glomerular Filtration Rate ≤ 25 ml/min/1.73m². * History of angioedema or unacceptable side effects during receipt of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB). * Structural mitral valve disease and previous or planned mitral valve intervention. * Already receiving angiotensin receptor neprilysin inhibitor (ARNI, sacubitril-valsartan) therapy. * Severe comorbid condition limiting life expectancy \< 24 months or inability to perform a maximal CPETecho. * Myocardial infarction, unstable angina, coronary revascularization within 12 weeks prior enrolment. * Severe aortic, tricuspid or pulmonary valve disease. * Pregnancy, lactation, or use of any method of contraception that is not highly effective.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Functional mitral regurgitation are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

diastolic heart failure mitral valve insufficiency

As listed by the trial registrant

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

Functional mitral regurgitation Heart failure with preserved ejection fraction

Contacts and locations

Locations

  • Ziekenhuis Oost-Limburg

    Genk, 3600, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.