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

Not yet recruiting

• Conditions: Diabetic Nephropathies; Heart Failure With Reduced Ejection Fraction; Diabetes Mellitus

• Registration Number: NCT05974566
• Lead Sponsor: Chongqing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study Start: 2023-08-01
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)	before and after 6 months of medication	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

Secondary Outcome Measures

Name	Time	Method
Composite endpoint of death and heart failure rehospitalization	during the 6-month period of medication therapy	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
Change in extracellular volume (ECV)	Before and after 3 months of continuous treatment	Extracellular volume (ECV) measured by cardiac magnetic resonance imaging (CMR) helps to demonstrate the improvement in myocardial fibrosis
Change in left ventricular ejection fraction (LVEF)	before and after 6 months of medication	The change in LVEF measured by echocardiogram
Change in renal function level	Before and after 3 months of continuous treatment	Change in estimated glomerular filtration rate(eGFR) reflect the renal function