Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction

Study Overview
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Brief Summary
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Finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (MRA), nowadays it's widely used in type 2 diabetes (T2DM) patients with chronic kidney disease (CKD), the newest trial shows finerenone improve the cardiovascular outcomes among patients with T2DM and CKD especially reduce the risk of hospitalization for heart failure. In patients with diabetic nephropathy, finerenone resulted in lower risks of CKD progression and cardiovascular events. Finerenone shows great potential therapeutic effect in chronic heart failure (CHF) patients with or without T2DM and CKD compared to eplerenone, but there is still no real world study on finerenone in patients with heart failure with reduced ejection fraction (HFrEF) and it's unclear about the effect of finerenone in CHF patients without T2DM and CKD. The investigators will conduct a study to demonstrate the efficacy and safety of finerenone in HFrEF patients compared to other MRAs.

Official Title
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Efficacy and Safety of Finerenone in Patients With Heart Failure With Reduced Ejection Fraction

Conditions
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Heart Failure With Reduced Ejection Fraction, Diabetes Mellitus, Diabetic Nephropathies

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years New York Heart Association(NYHA) functional classification II - IV LVEF measured by the echocardiogram ≤ 45% eGFR>25mL/min/1.73m² Exclusion Criteria: LVEF measured by the echocardiogram > 45% History of allergic or hypersensitivity to drugs involved in the trial. Patients with a known history of cancer, angioedema, significant congenital heart disease or rheumatic heart disease. Patients diagnosed with myocarditis. Probable alternative diagnoses could account for the patient's HF symptoms e.g., COPD, bronchial asthma, primary pulmonary hypertension. Systolic blood pressure (SBP) ≥180mmHg or diastolic blood pressure (DBP) 120mmHg at visit, DBP≤90mmHg or symptomatic hypotension. Patients with cardiac pacemaker Pregnant woman eGFR≤25mL/min/1.73m² and not accept long-term hemodialysis therapy. Serum potassium >5.2 mmol/l at visit Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate>150 bpm in AF patients. Obvious stenosis (≥50%) of bilateral renal arteries.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HFrEF patients who accept finerenone therapy<br>Patients with HFrEF receive finerenone 10mg or 20mg daily treatment for 3 months in addition to other medications. | |
| HFrEF patients who accept Spironolactone or eplerenone therapy<br>Patients with HFrEF receive spironolactone or eplerenone treatment daily treatment for 3 months in addition to other medications. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) | The change in serum NT-proBNP levels in patients was measured before medication and after 6 months of medication to determine the improvement on heart failure | before and after 6 months of medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint of death and heart failure rehospitalization | The composite endpoint include the death due to cardiovascular reasons, worsening of renal disease, rehospitalization due to heart failure and admission to hospital to accept intravenous diuretics therapy | during the 6-month period of medication therapy | 
| Change in left ventricular ejection fraction (LVEF) | The change in LVEF measured by echocardiogram | before and after 6 months of medication | 
| Change in extracellular volume (ECV) | Extracellular volume (ECV) measured by cardiac magnetic resonance imaging (CMR) helps to demonstrate the improvement in myocardial fibrosis | Before and after 3 months of continuous treatment | 
| Change in renal function level | Change in estimated glomerular filtration rate(eGFR) reflect the renal function | Before and after 3 months of continuous treatment |