Myocarditis Clinical Trial
— HYPICOfficial title:
The Efficacy and Mechanism of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy After Myocarditis
Evaluating the long-term therapeutic effects of hydroxychloroquine(compared to glucocorticoid therapy alone) in patients with inflammatory cardiomyopathy--a multicenter randomized controlled study
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital | Taihe Hospital, Wuhan Central Hospital |
China,
Hang W, Chen C, Seubert JM, Wang DW. Fulminant myocarditis: a comprehensive review from etiology to treatments and outcomes. Signal Transduct Target Ther. 2020 Dec 11;5(1):287. doi: 10.1038/s41392-020-00360-y. — View Citation
He W, Zhou L, Xu K, Li H, Wang JJ, Chen C, Wang D. Immunopathogenesis and immunomodulatory therapy for myocarditis. Sci China Life Sci. 2023 Sep;66(9):2112-2137. doi: 10.1007/s11427-022-2273-3. Epub 2023 Mar 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite incidence of cardiovascular death or heart transplant | Cardiovascular death was defined as death from cardiovascular causes and any unknown death unless there was another certain cause. | 3 years | |
Secondary | The increase and dynamic changes of LVEF (%) | Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up. | 3 years | |
Secondary | The decrease and dynamic changes of hs-cTnI (pg/mL) | 3 years | ||
Secondary | The decrease and dynamic changes of NT-proBNP (pg/mL) | 3 years |
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