Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07575672
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Finerenone
  • HFpEF - Heart Failure With Preserved Ejection Fraction
  • TAVI(Transcatheter Aortic Valve Implantation)

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Finerenone — DRUG
    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 — DRUG
    Oral treatment with placebo daily

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
2,832 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group
    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 Comparator: Control Group
    Oral treatment with placebo daily

Primary Outcome Measure

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. [ Time Frame: at least 12 months ]

Central Contacts

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