Status:
UNKNOWN
Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction
Lead Sponsor:
Chongqing Medical University
Conditions:
Heart Failure With Reduced Ejection Fraction
Diabetes Mellitus
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- New York Heart Association(NYHA) functional classification II - IV
- LVEF measured by the echocardiogram ≤ 45%
- eGFR\>25mL/min/1.73m²
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05974566
Start Date
August 1 2023
End Date
October 30 2023
Last Update
August 3 2023
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