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NOT YET RECRUITING
NCT07583173
PHASE4

Effect of Finerenone on Myocardial Fibrosis and Cardiac Function in HFmrEF/HFpEF Patients

Sponsor: China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

Summary

FINE-FOCUS study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of Finerenone versus placebo on myocardial fibrosis and cardiac structure/function as assessed by cardiac magnetic resonance (CMR) in symptomatic heart failure patients with a left ventricular ejection fraction (LVEF) ≥40%. A sub-study will include 18F-FAPI-PET/CT imaging to evaluate the effect of finerenone on myocardial fibrosis.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Finerenone on Myocardial Fibrosis and Cardiac Structure and Function in Heart Failure Patients With Mildly Reduced or Preserved Ejection Fraction

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-05-15

Completion Date

2027-12-31

Last Updated

2026-05-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

Oral finerenone

Standard heart failure therapy plus oral finerenone eGFR ≤60 mL/min/1.73 m²: Start 10 mg once daily, target 20 mg once daily. eGFR \>60 mL/min/1.73 m²: Start 20 mg once daily, target 40 mg once daily. Dose adjustments are mandated based on serum potassium levels and eGFR changes.

DRUG

Placebo

Standard heart failure therapy plus matching placebo

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

Beijing, China