Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 16, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07575672). This is a study registration, not published results. Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 2832 participants (ESTIMATED). Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction, TAVI(Transcatheter Aortic Valve Implantation), Finerenone. Interventions: DRUG: Finerenone; DRUG: Placebo. Primary outcome measures: 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. , at least 12 months. Brief 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.