Dilated cardiomyopathy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with dilated cardiomyopathy (DCM) aged =18 years, of either sex; 2. Patients who have achieved the standard of heart failure recovery with the new four-drug GDMT (or a three-drug regimen excluding MRA) for at least 6 months, and were evaluated at the time of enrollment to meet the standard of heart failure recovery, i.e., satisfying all of the following conditions: a. No typical symptoms and signs of heart failure in the past 6 months; b. An increase in LVEF of more than 10% and =50% within the past 6 months, and LVEDD<55mm; c. NT-proBNP<300pg/ml (for patients with eGFR<60ml/min/1.73m², NT-proBNP<450pg/ml); 3. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Poorly controlled hypertension, defined as resting systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg at two independent examinations prior to randomization; 2. Hepatic transaminases (ALT or AST) not caused by heart failure, bilirubin exceeding 3 times the upper limit of normal, estimated glomerular filtration rate (GFR) less than 15ml/min/1.73m^2; 3. Patients with hemoglobin concentration = 2 times the upper limit of normal or aspartate aminotransferase (AST> = 2 times the upper limit of normal), active hepatitis B hepatic insufficiency (ALT> = 2 times the upper limit of normal or aspartate aminotransferase (AST>=2 times the upper limit of normal), patients with active tuberculosis, etc.; 23. Patients with clearly diagnosed systemic diseases and autoimmune diseases, such as systemic lupus erythematosus and severe asthma; 24. Those who have participated in other drug clinical studies within 2 months; 25. Pregnancy (positive pregnancy test) or lactation; Childbearing age who a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of heart failure recurrence or heart failure events (hospitalization for heart failure, cardiovascular death); | — |
Secondary
| Measure | Time frame |
|---|---|
| Total number of hospitalizations for heart failure;Number of emergency or hospital admissions due to worsening heart failure;Cardiovascular death;All-cause mortality; | — |
Countries
China
Contacts
Chinese Academy of Medical Sciences Fuwai Hospital