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NCT07758023

Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF

Sponsor: University Medical Center Mainz

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

520

Start Date

2026-08-10

Completion Date

2030-09-30

Last Updated

2026-08-11

Healthy Volunteers

Conditions

Mitral Regurgitation Functional Heart Failure With Reduced Ejection Fraction (HFrEF)

Interventions

DEVICE

M-TEER

Transcatheter edge-to-edge repair (M-TEER) of the mitral valve, performed once, within 7 days of randomization, in subjects randomized to the Intervention arm.

OTHER

Standardized GDMT Up-Titration

A protocol-driven regimen applied to all randomized subjects, beginning at randomization (Control arm) or on the first post-procedural day (Intervention arm). Subjects are started on a beta-blocker, ACE inhibitor/ARB/ARNI, a mineralocorticoid receptor antagonist, and an SGLT2 inhibitor, targeting at least half of each drug's optimal dose immediately (full dose for the SGLT2 inhibitor), with same-day achievement recommended if hemodynamically stable. Formal reassessment occurs at 2, 4, 6, 8, 10, and 12 weeks, with up-titration to full optimal doses of beta-blocker, ACEi/ARB/ARNI, and MRA targeted by week 6, contingent on tolerability. Medications are not up-titrated if systolic blood pressure is \<95 mmHg, potassium is \>5.0 mmol/L, eGFR is \<30 mL/min/1.73m², or heart rate is \<55 bpm (beta-blocker only); diuretic dose reduction is encouraged if eGFR is \<30 mL/min/1.73m². Safety and tolerability are formally reassessed at weeks 2, 4, 6, 10, and 12.

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