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.
Aged 18 to 80 years (inclusive), any gender.
Symptomatic heart failure (NYHA class II-IV).
Emergency department visit or hospitalization for HF within the past 3 months, or escalation of intravenous or oral diuretic therapy for worsening HF within the past 3 months.
LVEF ≥40% measured by echocardiography or CMR within the past 30 days prior to screening.
1. eGFR <25 mL/min/1.73 m² at screening or enrollment. 2. Serum potassium concentration ≥5.0 mmol/L at screening or enrollment. 3. Prior confirmed diagnosis of HFrEF. 4. Acute inflammatory heart disease (e.g., acute myocarditis). 5. Acute myocardial infarction or other event likely to have reduced LVEF within 30 days prior to randomization.
Parallel
Oral finerenone
DrugStandard 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.
Placebo
DrugStandard heart failure therapy plus matching placebo
Change in CMR-measured extracellular volume (ECV) from baseline to Month 6 (∆ECV = ECV[post-treatment] - ECV[baseline])
Change from baseline to 6 months in CMR-measured parameter: left ventricular end-diastolic volume index
Change from baseline to 6 months in CMR-measured parameter: left ventricular end-systolic volume index
Change from baseline to 6 months in CMR-measured parameter: left ventricular mass index
Change from baseline to 6 months in CMR-measured parameter: left ventricular ejection fraction
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