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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05961202
Other study ID # TJ-HYPIC
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date January 1, 2022
Est. completion date June 1, 2025

Study information

Verified date June 2024
Source Tongji Hospital
Contact Dao Wen Wang, MD, PhD
Phone +86-027-6937-8422
Email dwwang@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Inflammatory cardiomyopathy is the chronic stage of myocarditis, which is associated with poor cardiovascular outcome and poor prognosis.Inflammatory cardiomyopathy is also one of the common causes of heart failure. Actually, the treatment and prognosis of inflammatory cardiomyopathy remain challenging clinical issues that often have frustrating consequences. So far, there is no specific treatment for inflammatory cardiomyopathy. Hydroxychloroquine is a drug that can effectively inhibit inflammation and has been used in many inflammatory diseases in the past. Our previous basic research has proved that hydroxychloroquine can effectively treat experimental autoimmune myocarditis.Therefore, multicenter large randomized controlled trials are needed to verify the therapeutic effects of hydroxychloroquine on patients with inflammatory cardiomyopathy. Patients with inflammatory cardiomyopathy after acute myocarditis confirmed by biopsy received standard drug treatment for heart failure. These patients whose cardiac function could not be improved for a long time were randomly assigned (1:1) to hydroxychloroquine group (hydroxychloroquine and glucocorticoid) and glucocorticoid group (glucocorticoid alone). The clinical benefit will be measured with respect to absolute increase in LVEF and decrease in hs-cTnI and NT-proBNP of immunosuppressive treatment with hydroxychloroquine and prednisolone compared to prednisolone alone at long-term follow-up (6, 12, 18, 24, 36 months).


Recruitment information / eligibility

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;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hydroxychloroquine
Hydroxychloroquine 200mg qd
Prednisolone
Prednisolone 20mg qd

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (3)

Lead Sponsor Collaborator
Tongji Hospital Taihe Hospital, Wuhan Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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

Outcome

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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