Chronic heart failure with reduced ejection fraction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.18 years old = 450 pg/mL; 50-74 years old >= 900 pg/mL; >= 75 years old (including 75 years old) >= 1800 pg/mL; 3.Left ventricular ejection fraction (LVEF) < 45%; New York Heart Association (NYHA) functional class II to IV; 4.Hospitalization due to worsening heart failure in the past 6 months or receiving intravenous diuretic therapy in outpatient clinics in the past 3 months; 5.The baseline NT-proBNP level can be measured;
Exclusion criteria
Exclusion criteria: 1.Systolic blood pressure < 100 mmHg or symptomatic hypotension; 2.Waiting for a heart transplant or receiving continuous intravenous inotropic therapy; 3.Amyloidosis, sarcoidosis, hypertrophic cardiomyopathy, myocarditis, or stress cardiomyopathy; 4.Tachycardiomyopathy or uncontrolled tachycardia; 5.Constrictive pericarditis or endocarditis; 6.Severe renal insufficiency (glomerular filtration rate < 15ml/min/1.73m2), or receiving chronic dialysis treatment; 7.Severe hepatic insufficiency; 8.Primary valvular heart disease requiring intervention, or having undergone valve intervention within 3 months before randomization; 9.Having symptomatic carotid artery stenosis, transient ischemic attack, or stroke within 3 months before randomization; 10.Complex congenital heart disease, or simple congenital heart disease with residual hemodynamic lesions; 11.Previous heart transplantation or mechanical circulatory support; 12.Malignant tumors or other non-cardiac diseases that limit life expectancy to less than 3 years; 13.Continuous home oxygen therapy or interstitial lung disease; 14.During the study period, it is expected that phosphodiesterase type 5 inhibitors (such as sildenafil, tadalafil, vardenafil) or other soluble guanylate cyclase stimulators (such as riociguat) will be used, either concurrently or as anticipated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First hospitalization for heart failure;Adverse cardiovascular events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ), NYHA Functional Classification;White blood cell (WBC), hemoglobin (HB), serum potassium (K), creatinine (Cr), creatinine clearance rate (eGFR), alanine transaminase (ALT), aspartate transaminase (AST);N-terminal B-type natriuretic peptide precursor (NT-proBNP), left ventricular ejection fraction (EF), left ventricular end-diastolic diameter; | — |
Countries
China
Contacts
Jilin Province FAW General Hospital