Finerenone in patients having TAVI with heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, double-blind, randomized, placebo-controlled phase 3 trial evaluating finerenone in patients with symptomatic severe aortic stenosis undergoing TAVI and heart failure with LVEF ≥ 40%. Participants are randomly assigned to finerenone or placebo and followed for up to 3 years, with key assessments including serum potassium and kidney function monitoring and serial follow-ups at 30 days, 12 months, and then every 6 months after the first year. The primary endpoint is a composite of all-cause mortality or worsening heart failure. Eligibility requires age ≥65, severe aortic stenosis treated with transfemoral TAVI, NYHA class II or higher, and LVEF ≥40% at baseline, among other criteria. Exclusion criteria include hyperkalemia, very reduced kidney function, recent major cardiac events, and contraindications to mineralocorticoid receptor antagonists.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Not yet recruiting
• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, Anhui, China Not yet recruiting
• Affiliated Beijing Chaoyang Hospital of Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Anzhen Hospital Affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• Chinese People's Liberation Army General Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Jian'an Wang, MD, PhD
• Email: wangjianan111@zju.edu.cn
• Phone: +86-571-8778-4808

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.