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Early Mitral Valve Repair to Help Reach Full Heart Failure Medication Doses

Tests early mitral valve repair in adults with weak-pumping heart failure and leaky valve.

Key facts

Who runs it
University Medical Center Mainz
Where
Mainz, GermanySee the site
Trial code
Registry title
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Status
Recruiting
People taking part
520 people, planned
Started
15 Oct 2026
Expected to end
30 Sept 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • M-TEER
  • Standardized GDMT Up-Titration
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with heart failure with a weak heart pump and significant leaky mitral valve, whose heart medicines are not yet fully built up and may be hard to increase.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Heart failure with reduced ejection fraction (left ventricular ejection fraction ≤40%). Moderate-to-severe or severe functional mitral regurgitation within 90 days before randomization. Symptoms of NYHA class II-IVa while walking about (ambulatory). At least one heart failure hospital stay within 12 months and/or NT-proBNP ≥1000 pg/ml.
Earlier treatment
Heart failure medicine (GDMT) not at full level, with a GDMT score <7 points. Must have at least one reason that makes increasing the medicine hard: office systolic blood pressure <120 mmHG, chronic kidney failure with eGFR <60 ml/min/1.73m, acute kidney injury of at least stage 2 within 12 months, or serum potassium ≥ 4.8 mmol/L.
Biomarker or test result
Mitral regurgitation by EROA ≥0.2 cm² and/or regurgitant fraction >30%. NT-proBNP ≥1000 pg/ml (if no heart failure hospital stay within 12 months).

Main reasons for not taking part

  • Terminal heart failure or unstable circulation
  • Kidney failure needing dialysis
  • Primary mitral or tricuspid valve disease or other severe valve disease
  • Life expectancy under 12 months from other (non-heart) conditions
  • Pregnant, nursing, or planning pregnancy

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction ≤40%)
  • 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%)
  • Suboptimal GDMT therapy corresponding to a GDMT score <7 points
  • Risk factor for not intensification of guideline directed medical therapy (at least one of the following):; Office systolic blood pressure <120 mmHG; Chronic renal failure with eGFR <60 ml/min/1.73m; History of acute kidney injury (AKI) at least stage 2 within the last 12 months; Serum Potassium ≥ 4.8 mmol/L
  • Persisting symptoms equalling NYHA functional class II-IVa (ambulatory)
  • Patient has had at least one HF hospitalization within 12 months and/or a NT-proBNP ≥1000 pg/ml
  • Interventional cardiologist believes secondary MR can be successfully treated by an interventional approach
  • 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

Who cannot take part

  • Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator
  • 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
  • Terminal heart failure or hemodynamic instability
  • Primary TR or MR, any other severe valvular heart disease
  • Untreated clinically significant CAD (coronary artery disease) requiring revascularization
  • Renal failure requiring dialysis
  • Life expectancy <12 months due to non-cardiac conditions
  • Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
  • Active infections requiring current antibiotic therapy
  • Known hypersensitivity or contraindication to procedural device which cannot be adequately managed medically
  • LVEF <35% and left bundle branch block with a QRS duration >150 ms
  • Mitral valve orifice area <4.0 cm² by site assessed TTE
  • KCCQ score > 80 points
  • Patient is pregnant, nursing, or planning to be pregnant
  • Ineligibility to consent

Where in Germany

  • Universitätsmedizin MainzMainz, GermanyContact: Karl-Patrik Kresoja, MDTaking people

About the trial

What the trial wants to find out

The purpose of the ACHILLES-HF trial (ACHIeving optimaL medicaL therapy through pErcutaneous treatment of Secondary mitral regurgitation to improve outcome in Patients with Heart Failure with reduced ejection fraction) is to test whether early transcatheter edge-to-edge repair (TEER) in patients with heart failure and reduced ejection fraction (HFrEF) and relevant secondary mitral regurgitation, that are at risk of not receiving full guideline recommended therapy (GDMT), results in faster and more complete GDMT up-titration and whether this translates into improved quality of life and clinical outcomes.

The 2 groups in the trial

  • Intervention groupTreatment being tested

    Subjects randomized to this arm undergo transcatheter edge-to-edge repair (M-TEER) of the mitral valve within 7 days of randomization, in addition to a standardized, protocol-driven guideline-directed medical therapy (GDMT) up-titration regimen. Starting on the first post-procedural day, subjects are up-titrated toward optimal target doses of a beta-blocker, ACE inhibitor/ARB/ARNI, a mineralocorticoid receptor antagonist, and an SGLT2 inhibitor, guided by protocol-defined thresholds for blood pressure, heart rate, potassium, and renal function, with formal safety/tolerability reassessment at 2, 4, 6, 8, 10, and 12 weeks.

    Treatment: M-TEER and Standardized GDMT Up-Titration

  • Control groupExisting treatment, for comparison

    Subjects randomized to this arm receive the identical standardized, protocol-driven GDMT up-titration regimen as the Intervention group, without early M-TEER. Up-titration toward optimal target doses of a beta-blocker, ACE inhibitor/ARB/ARNI, a mineralocorticoid receptor antagonist, and an SGLT2 inhibitor begins at randomization and follows the same protocol-defined safety thresholds and visit schedule (2, 4, 6, 8, 10, and 12 weeks) as the Intervention group. Subjects may cross over to M-TEER or mitral valve surgery after completion of the 12-week follow-up visit, or earlier in the case of an intervening heart failure hospitalization.

    Treatment: Standardized GDMT Up-Titration

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Plain-language title
Early Mitral Valve Repair to Help Reach Full Heart Failure Medication DosesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 November 2026