Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure (NCT07575672) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure
China2,832 participantsStarted 2026-07-01
Plain-language summary
This study is a multicenter, double-blind, randomized, placebo-controlled trial. The purpose is to evaluate whether treatment with finerenone in patients with symptomatic severe aortic stenosis undergoing TAVI, and heart failure with LVEF ≥40% is associated with a reduction in the composite endpoint of all-cause mortality or worsening of heart failure. Participants are patients with symptomatic aortic stenosis undergoing TAVI and heart failure with LVEF≥40%. Eligible patients will be randomly assigned in a 1:1 ratio to either the finerenone group or the placebo group. Patients meeting all inclusion criteria and not any exclusion criteria will be invited to participate before discharge. All enrolled patients will consecutively receive treatment, during which serum potassium and estimated glomerular filtration rate will be closely monitored. Follow-up will be conducted at 30 days, 12 months at clinic, and 3 months, 6 months, 9 months and every 6 months after 12 months of enrollment online or via telephone (at clinic if necessary). The final visit will be conducted for all enrolled patients at the end of the study.
Who can participate
Age range
65 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
. Age ≥ 65 years.
. Patients with severe aortic stenosis (aortic valve area \< 1.0 cm2 or indexed area \< 0.6 cm2/m2, or mean transvalvular aortic gradient ≥ 40 mmHg or velocity of blood flow through the valve ≥ 4.0 m/s) undergoing transfemoral TAVI.
. New York Heart Association class ≥ II.
. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
. Informed consent has been signed.
Exclusion criteria
. Untreated serum/plasma potassium \> 5.0 mmol/L during the screening period or randomization visit.
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
A composite of all-cause mortality or worsening of heart failure (hospitalization for HF or urgent HF visit), any of the first occurrence during the follow-up.
Timeframe: at least 12 months
Trial details
NCT IDNCT07575672
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. Estimated glomerular filtration rate \< 25 ml/min/1.73 m².
. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
. Pregnant or breastfeeding patients.
. Life expectancy \< 1 year.
. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.