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ClinicalTrials.gov ID

NCT07575672

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

2,832Estimated

Last Update Posted

May 8, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

Official Title

Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial

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.

Detailed Description

Inclusion criteria:

1. Age ≥ 65 years.
2. 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.
3. New York Heart Association class ≥ II.
4. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
5. Informed consent has been signed.

Exclusion criteria:

1. Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
2. Estimated glomerular filtration rate < 25 ml/min/1.73 m².
3. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
4. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
5. Pregnant or breastfeeding patients.
6. Life expectancy < 1 year.
7. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

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

• Finerenone
• Placebo

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Age ≥ 65 years.
2. 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.
3. New York Heart Association class ≥ II.
4. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
5. Informed consent has been signed.

Exclusion Criteria:

1. Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
2. Estimated glomerular filtration rate < 25 ml/min/1.73 m².
3. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
4. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
5. Pregnant or breastfeeding patients.
6. Life expectancy < 1 year.
7. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER

huangqiong@126.com+86-13783568750

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liujinping@znhospital.cn+86-13986127672

wangdongjin@163.com+86-19822812099

jameszll@163.com+86-18951670357

guipengan@hotmail.com+86-15288872003

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