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

Chongqing Medical University

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05974566

2023-07

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

HFrEF patients who accept finerenone therapy

Description:

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

Description:

Patients with HFrEF receive spironolactone or eplerenone treatment daily treatment for 3 months in addition to other medications.