Can a valve fix unlock better heart failure drugs?
NCT ID NCT07758023
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
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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
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About 520 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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