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NCT Number: NCT07575672

Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, China

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About this study

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Total number of worsening of heart failure.

    Time frame: at least 12 months

  2. Total number of worsening of heart failure and cardiovascular mortality.

    Time frame: at least 12 months

  3. Total number of worsening of heart failure and all-cause mortality.

    Time frame: at least 12 months

  4. Time to cardiovascular mortality.

    Time frame: at least 12 months

  5. Time to all-cause mortality.

    Time frame: at least 12 months

  6. Time to first worsening of heart failure.

    Time frame: at least 12 months

  7. Time to cardiovascular mortality or first worsening of heart failure.

    Time frame: at least 12 months

  8. Time to cardiovascular mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes.

    Time frame: at least 12 months

  9. Time to all-cause mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes.

    Time frame: at least 12 months

  10. Change from baseline in KCCQ score at 30-day and 12-month follow-up.

    Time frame: 30-day and 12-month follow-up

  11. Improvement from baseline in NYHA classification at 30-day and 12-month follow-up.

    Time frame: 30-day and 12-month follow-up

  12. Change from baseline in LVMI at 30-day and 12-month follow-up.

    Time frame: 30-day and 12-month follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Jian'an Wang, MD, PhD

CONTACT

[email protected]

+86-571-8778-4808

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: FINE-VALUE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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