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

NCT07758023 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-08-11

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • University Medical Center Mainz

    lead OTHER

Principal Investigators

  • Philipp Lurz, Prof · Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2030-09-30
Completion
2030-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758023 on ClinicalTrials.gov