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

Launched by CHONGQING MEDICAL UNIVERSITY · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called finerenone, which is designed to help patients with heart failure that has reduced ejection fraction (HFrEF). Heart failure means that the heart doesn’t pump blood as well as it should. This trial aims to see if finerenone can improve heart health, especially in patients who also have diabetes and kidney problems. Researchers are particularly interested in how well finerenone works compared to other similar medications and whether it is safe for people with HFrEF.

To participate in this trial, you need to be at least 18 years old and have certain heart-related conditions, such as a specific level of heart function measured by an echocardiogram. You also need to have good enough kidney function. However, some individuals, including those with certain heart issues, high blood pressure, or specific medical histories, cannot join the study. If you take part, you can expect to receive careful monitoring and support from the research team while they gather important information about the effects of finerenone on heart failure. This trial is not yet recruiting participants but could provide valuable insights into new treatment options for heart failure in the future.

Gender

ALL

Eligibility criteria

• 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.