Standardized GDMT Up-Titration / M-TEER / Mitral Regurgitation Functional · Interventional Study

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

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

The ACHILLES-HF trial is a planned randomized study comparing early transcatheter edge-to-edge repair (TEER) combined with standardized GDMT up-titration versus GDMT alone in patients with HFrEF and secondary mitral regurgitation. No results are yet reported in this registry record; the study aims to assess whether TEER accelerates GDMT titration and improves quality of life and 24-month cardiovascular outcomes.

What was studied

Interventional, Randomized, Parallel, Open label, Treatment purpose. Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF); age from 18 Years. Intervention: Intervention group. Compared with: Control group — Active Comparator. n = 520.

Key findings

Safety

This is a registry record with no results reported; no efficacy, safety, or outcome data are available.

Who this may help

This trial is not yet powered to influence clinical practice. Once results are available, clinicians should evaluate whether early TEER improves GDMT tolerability and hard clinical outcomes in HFrEF patients with secondary mitral regurgitation.

Plain-language summary

This is a planned interventional trial with no results reported; the registry record describes design and primary outcomes only, making it hypothesis-generating until data are available.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Difference in Guideline-Directed Medical Therapy (GDMT) Score at 12 Weeks (assessed at Baseline and 12 weeks post-randomization (post-procedure for Intervention group)); Difference in Quality of Life (KCCQ Score) at 12 Weeks (assessed at Baseline and 12 weeks post-randomization (post-procedure for Intervention group…); Composite of Cardiovascular Death or First Heart Failure Hospitalization at 24 Months (assessed at From randomization to 24 months)

DesignInterventional, Randomized, Parallel, Open label, Treatment purpose

PopulationMitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF); age from 18 Years

Sample size520

InterventionIntervention group

ComparatorControl group — Active Comparator

Reported figures

Quoted from the source exactly as published.

Planned enrollment520

Primary outcome 1Difference in GDMT Score at 12 weeks (baseline and post-randomization/procedure)

Primary outcome 2Difference in Quality of Life (KCCQ Score) at 12 weeks (baseline and post-randomization/procedure)

Primary outcome 3Composite of Cardiovascular Death or First Heart Failure Hospitalization at 24 months

Clinical bottom line

Caveats

This is a registry record with no results reported; no efficacy, safety, or outcome data are available.
Randomization method, blinding status, and detailed inclusion/exclusion criteria are not described.
Follow-up duration is 24 months for the primary composite outcome; longer-term durability is not assessed.
Comparator arm definition (standard GDMT alone) is not explicitly detailed in the registry summary.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized interventional trial design stated; phase not specified.

Directness

strong

Direct comparison of percutaneous TEER plus GDMT vs GDMT alone in HFrEF.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record.

Risk of bias

insufficient

No methodology detail on blinding, allocation concealment, or conduct reported.

Sample adequacy

moderate

Planned enrollment 520 participants; adequacy for stated outcomes unclear.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07758023). This is a study registration, not published results. Lead sponsor: University Medical Center Mainz. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 520 participants (ESTIMATED). Conditions: Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF). Interventions: DEVICE: M-TEER; OTHER: Standardized GDMT Up-Titration. Primary outcome measures: Difference in Guideline-Directed Medical Therapy (GDMT) Score at 12 Weeks , Baseline and 12 weeks post-randomization (post-procedure for Intervention group); Difference in Quality of Life (KCCQ Score) at 12 Weeks , Baseline and 12 weeks post-randomization (post-procedure for Intervention group), among surviving patients; Composite of Cardiovascular Death or First Heart Failure Hospitalization at 24 Months , From randomization to 24 months. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Standardized GDMT Up-TitrationM-TEERMitral Regurgitation FunctionalHeart Failure With Reduced Ejection Fraction (hfref)NCT07758023University Medical Center Mainz