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Can a valve fix unlock better heart failure drugs?

NCT ID NCT07758023

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial tests whether repairing a leaky mitral valve early, using a minimally invasive clip procedure, can help people with heart failure and reduced pumping function tolerate and benefit from standard heart failure medications. Participants are randomly assigned to receive the valve repair plus a structured medication plan, or the medication plan alone. The study measures how well medications are optimized, quality of life, and long-term outcomes like hospitalizations and survival.

What this could mean

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

Active substance
Transcatheter edge-to-edge repair (M-TEER) of the mitral valve, plus a standardized regimen of heart failure medications
What this could lead to
If successful, this approach could help heart failure patients get on full, life-saving medications faster and improve their quality of life and survival.
What could go wrong
The procedure carries risks, and it's unclear if early valve repair will truly enable better medication tolerance or improve long-term outcomes.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 520 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

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 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

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

Inclusion Criteria: 1. Heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction ≤40%) 2. Clinically significant functional mitral regurgitation (moderate-to severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization (i.e. EROA ≥0.2 cm² and/or regurgitant fraction \>30%) 3. Suboptimal GDMT therapy corresponding to a GDMT score \<7 points 4. Risk factor for not intensification of guideline directed medical therapy (at least one of the following): 1. Office systolic blood pressure \<120 mmHG 2. Chronic renal failure with eGFR \<60 ml/min/1.73m 3. History of acute kidney injury (AKI) at least stage 2 within the last 12 months 4. Serum Potassium ≥ 4.8 mmol/L 5. Persisting symptoms equalling NYHA functional class II-IVa (ambulatory) 6. Patient has had at least one HF hospitalization within 12 months and/or a NT-proBNP ≥1000 pg/ml 7. Interventional cardiologist believes secondary MR can be successfully treated by an interventional approach 8. The subject has been informed of the nature of the study and agrees to the study's provisions, including the possibility of randomization to the Control group, and has provided written informed consent as approved by the respective clinical site's Ethics Committee Exclusion Criteria: 1. Terminal heart failure or hemodynamic instability 2. Primary TR or MR, any other severe valvular heart disease 3. Untreated clinically significant CAD (coronary artery disease) requiring revascularization 4. LVEF \<35% and left bundle branch block with a QRS duration \>150 ms 5. Renal failure requiring dialysis 6. Mitral valve orifice area \<4.0 cm² by site assessed TTE 7. Life expectancy \<12 months due to non-cardiac conditions 8. KCCQ score \> 80 points 9. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated) 10. Active infections requiring current antibiotic therapy. 11. Known hypersensitivity or contraindication to procedural device which cannot be adequately managed medically. 12. Patient is pregnant, nursing, or planning to be pregnant 13. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator. 14. Currently participating in another investigational therapeutic or interventional clinical trial, or in any trial of an unapproved drug, device or procedure. Note: Subjects participating in observational studies or registries may be considered as eligible. 15. Ineligibility to consent

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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.

How to take part

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

  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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