The Efficacy and Mechanism of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy After Myocarditis

TJ-HYPIC

Evaluating the long-term therapeutic effects of hydroxychloroquine(compared to glucocorticoid therapy alone) in patients with inflammatory cardiomyopathy--a multicenter randomized controlled study

2022-01-01

2024-06-01

2025-06-01

Recruiting

Early phase I

200

Inclusion Criteria: 1. Age 18-80 years; 2. Heart failure NYHA II-IV; 3. Patients with myocarditis confirmed by myocardial biopsy in the past; 4. Standard treatment for heart failure \> 6 months; 5. Persistent reduction of LVEF \<50% on a routine echocardiographic evaluation (Simpson's biplane) not older than 1 month at time of inclusion; 6. hs-cTnI \>26.5pg/mL or NT-proBNP\>169 pg/mL； Exclusion Criteria: 1. Age \<18 or \>80 years; 2. Known or possible systemic inflammatory disease; 3. Patient on the brink of death or life expectancy\<1 year； 4. Drug or alcohol abuse; 5. Pregnancy or lactation; 6. Patients who cannot persist in taking medication due to various reasons; 7. Inability to provide informed consent;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-06-05