Achieving Optimal Medical Therapy Through Transcatheter Mitral Repair in HFrEF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ACHILLES-HF is an interventional study evaluating if adding early M-TEER to standard care accelerates up-titration to guideline-directed medical therapy in patients with heart failure with reduced ejection fraction and functional mitral regurgitation. Participants must have suboptimal GDMT and signs that they might not receive full GDMT due to risk factors or symptoms. The study uses M-TEER plus standardized GDMT up-titration and follows patients for changes in therapy, quality of life, and clinical outcomes. The trial is led by Universitätsmedizin Mainz with collaboration from Abbott. Enrollment focuses on patients with HFrEF, significant MR, and likelihood of benefiting from MR reduction to enable GDMT optimization.

Why it matters

Who can join: the full rules

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

Where it's running

• Universitätsmedizin Mainz
  Mainz, Rhineland-Palatine, Germany Recruiting

Study contacts

• Principal investigator: Philipp Lurz, Prof — Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz
• Study coordinator: Karl-Patrik Kresoja, MD
• Email: Achilles-HF@unimedizin-mainz.de
• Phone: +49 6131 178163

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Atrial Shunt to Help Heart Failure With Reduced Ejection Fraction

  This study tests whether an atrial shunt implanted after heart catheterization helps people with HFrEF when added to standard heart failure therapy.

  Recruiting Phase 2/3 Beijing Anzhen Hospital · Beijing, Beijing Municipality · NCT07820410

• CRD-4730 for heart failure with reduced ejection fraction

  This trial tests CRD-4730 versus placebo to see if it helps adults with HFrEF who are already on standard heart failure therapy.

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• Mitral Valve Edge-to-Edge Repair for exercise-induced severe mitral regurgitation in heart failure patients

  This trial tests whether adding mitral valve TEER to standard heart failure treatment helps people with exercise-triggered severe mitral regurgitation feel better and stay healthier.

  Recruiting at 2 sites Jena University Hospital · Düsseldorf and 1 other locations · NCT07709208

• Olive oil supplementation during cardiac rehab for heart failure with reduced ejection fraction

  This study tests whether adding extra-virgin olive oil during a cardiac rehabilitation program is doable and helpful for people with HFrEF.

  Recruiting Old Dominion University · Norfolk, Virginia · NCT07644806

• Remote-guided medication up-titration for people with reduced ejection fraction heart failure

  This trial will see if telemedicine follow-up helps clinicians start and increase guideline-recommended heart failure medicines faster and more completely in adults with newly diagnosed HFrEF.

  Recruiting Azienda Unita Sanitaria Locale di Piacenza · Piacenza · NCT07518030

• Nyra CARLEN System for Functional Mitral Regurgitation

  A first-in-human-feasibility test to see if the CARLEN system is safe and can perform well in people with symptomatic functional mitral valve regurgitation.

  Recruiting at 3 sites Nyra Medical, Inc. · Sacramento, California and 2 other locations · NCT07503236

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.