Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure

Starting soon · Phase 3 · Has a placebo group

Conditions studied: HFpEF - Heart Failure With Preserved Ejection Fraction, TAVI(Transcatheter Aortic Valve Implantation), Finerenone

In brief

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 facts

Study ID

NCT07575672

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

2832

Starts

2026-07-01

Expected to finish

2029-12-31

Last updated by the study team

2026-05-08

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
• 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.

Where it is running

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China
• Affiliated Beijing Chaoyang Hospital of Capital Medical University — Beijing, Beijing Municipality, China
• Beijing Anzhen Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China
• Chinese People's Liberation Army General Hospital — Beijing, Beijing Municipality, China
• Fuwai Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
• Peking University Third Hospital — Beijing, Beijing Municipality, China
• Army Medical Center of the People's Liberation Army — Chongqing, Chongqing Municipality, China
• The First Affiliated Hospital of Army Medical University — Chongqing, Chongqing Municipality, China
• The Second Affiliated Hospital of Army Medical University — Chongqing, Chongqing Municipality, China
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China
• Fuzhou University Affiliated Provincial Hospital — Fuzhou, Fujian, China
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• Fuwai Huazhong Cardiovascular Hospital — Zhengzhou, Henan, China
• Henan Chest Hospital — Zhengzhou, Henan, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Zhengzhou No.7 People's Hospital — Zhengzhou, Henan, China
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China
• The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China

Full record on ClinicalTrials.gov

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