Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitatio… (NCT07758023) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
520 participantsStarted 2026-08-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Guideline-Directed Medical Therapy (GDMT) Score at 12 Weeks
Timeframe: Baseline and 12 weeks post-randomization (post-procedure for Intervention group)
2
Difference in Quality of Life (KCCQ Score) at 12 Weeks
Timeframe: Baseline and 12 weeks post-randomization (post-procedure for Intervention group), among surviving patients
3
Composite of Cardiovascular Death or First Heart Failure Hospitalization at 24 Months