Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure

Condition(s) studied

Investigational drug(s) / intervention(s)

Finerenone: Oral treatment with finerenone daily: * For participants with an eGFR ≤60 mL/min/1.73 m2: Starting dose is 10 mg OD and target dose 20 mg OD. * For participants with an eGFR \>60 mL/min/1.73 m2: Starting dose is 20 mg OD and target dose 40 mg OD.

Placebo: Oral treatment with placebo daily

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (61)

+ 21 more sites — see the full list on the official registry below.

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition