Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure

Official title

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

Overview

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.

Interventions

• Drug Finerenone
  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.
• Drug Placebo
  Oral treatment with placebo daily

Primary outcome measures

• 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 outcome measures (12)

• Total number of worsening of heart failure. [Time frame: at least 12 months]
• Total number of worsening of heart failure and cardiovascular mortality. [Time frame: at least 12 months]
• Total number of worsening of heart failure and all-cause mortality. [Time frame: at least 12 months]
• Time to cardiovascular mortality. [Time frame: at least 12 months]
• Time to all-cause mortality. [Time frame: at least 12 months]
• Time to first worsening of heart failure. [Time frame: at least 12 months]
• Time to cardiovascular mortality or first worsening of heart failure. [Time frame: at least 12 months]
• Time to cardiovascular mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes. [Time frame: at least 12 months]
• 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]
• Change from baseline in KCCQ score at 30-day and 12-month follow-up. [Time frame: 30-day and 12-month follow-up]
• Improvement from baseline in NYHA classification at 30-day and 12-month follow-up. [Time frame: 30-day and 12-month follow-up]
• Change from baseline in LVMI at 30-day and 12-month follow-up. [Time frame: 30-day and 12-month follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 61 centers

• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• The First Affiliated Hospital of University of Science and Technology of China — Hefei
• Affiliated Beijing Chaoyang Hospital of Capital Medical University — Beijing
• Beijing Anzhen Hospital Affiliated to Capital Medical University — Beijing
• Chinese People's Liberation Army General Hospital — Beijing
• Fuwai Hospital Chinese Academy of Medical Sciences — Beijing
• Peking University Third Hospital — Beijing
• Army Medical Center of the People's Liberation Army — Chongqing
• … and 53 more centers

Identifiers

NCT: NCT07575672 · 2026-0377

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗