The Effects of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy

Myocarditis Clinical Trial

— HYPIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961202
• Other study ID #: TJ-HYPIC
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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;

Related Conditions & MeSH terms

• Cardiomyopathies
• Inflammatory Cardiomyopathy
• Myocarditis

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