Heart failure
Conditions
Interventions
Control group:Placebo
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, previously diagnosed with chronic congestive heart failure (NYHA class II-IV),hospitalizeddue todecompensatedheart failure(condition becomes stable) or within 3 months from discharge after hospitalization due to decompensatedheart failure, at the screening visit; 2. >=18 years ofage and less than 80 years old at the screening visit; 3. Having received guideline-recommended heart failure drug therapy (GMDT), including beta-blockers, ACEi, ARB, MRA, ARNI and/or SGLT2is before heart failure decompensation; If a patient is unable to receiveguideline-based treatments, reasons should be documented inthe case report form (CRF). 4. Within 12 months prior to randomization,patients must have a definitive LVEF value less than 40% (if there is more than one LVEF result, the most recent one should be used and it should be less than 40%). LVEF should be determined by one of the following methods: echocardiography, cardiac magnetic resonance or left ventriculography; 5. Plasma hsCRP>=5mg/L; 6. Before randomization, the condition of the subjects is relatively stable, and all intravenous drugs (including intravenous diuretics) have been discontinued; 7. The patients should meet one of the following criteria: (1) Male; (2) Female but not of child-bearing age; (3) Females of child-bearing age but agree and accept contraceptive measures throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Cardiogenic shock; 2. Obvious bleeding tendency or hematological disorders,or bone marrow suppression; 3. Bronchial asthma or severe obstructive pulmonary disease; 4. Severe renal insufficiency (eGFR=3 times the upper limit of the normal range (ULN); 6. Severe gastrointestinal diseases, such as gastrointestinal malignant tumors, recurrent gastrointestinal ulcers, severe diarrhea in the past one month, etc; 7. Having suffered fromacute myocardial infarction, ischemic or hemorrhagic stroke within the past three months, or are currently planning to undergo coronary, carotid or peripheral artery revascularization or valve surgery; 8. Severe immune system disease, or gout, or need to use uric acid-lowering treatment, steroid anti-inflammatory drugs,cytotoxic drugs or colchicine; 9. Patients taking strong CYP3A4 inhibitors (atazanavir, itraconazole, clarithromycin, diltiazem, etc.) or P-gp inhibitors (verapamil, erythromycin, cyclosporine, quinidine, propafenone, etc.); 10. Females who are pregnant, lactating or planning to become pregnant; 11. Acute or severe systemic infection; 12. Subjects who are participating in clinical trials of other drugs or medical devices; 13. Any known drug or alcohol dependence, having difficulty in understanding the research protocol, inability or unwillingness to follow the trial protocol; 14. Moderate to severe cognitive impairment without long-term fixed guardian; 15. Planning to have heart transplantation or left ventricular assist device implantation; 16. Considered by the investigator to be inappropriate to participate in this trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Cardiac function;Inflammation biomarkers;Activity tolerance; | — |
Primary
| Measure | Time frame |
|---|---|
| Compound end point event; | — |
Countries
China
Contacts
Public ContactBiao Xu
Nanjing Drum Tower Hospital
Outcome results
None listed