The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy

Phase 2

Recruiting

• Conditions: Inflammatory Cardiomyopathy; Myocarditis
• Interventions: Drug: Hydroxychloroquine; Drug: Prednisolone

• Registration Number: NCT05961202
• Lead Sponsor: Tongji Hospital

Brief Summary

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

Detailed 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 (1, 3, 6, 9, 12, 18, 24, 36 months).

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Study First Posted: 2023-07-27
• Primary Completion: 2024-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-06
• Last Update Posted: 2024-10-09
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCQ group	Hydroxychloroquine	Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months
HCQ group	Prednisolone	Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months
Non-HCQ group	Prednisolone	Prednisolone 20mg qd for 12 months

Primary Outcome Measures

Name	Time	Method
Composite cardiovascular outcome	3 years	The composite cardiovascular outcome of time to cardiovascular death or heart transplant, hospitalization for heart failure or recurrence of myocarditis, permanent pacemaker use, or ICD implantation.

Secondary Outcome Measures

Name	Time	Method
The decrease and dynamic changes of hs-cTnI (pg/mL)	3 years
The decrease and dynamic changes of NT-proBNP (pg/mL)	3 years
The decrease and dynamic changes of hs-CRP (mg/L)	3 years
The decrease and dynamic changes of ESR (mm/H)	3 years
The increase and dynamic changes of LVEF (%)	3 years	Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up.
The increase and dynamic changes of LVIDd (mm)	3 years	Measurement of left ventricular internal diastolic diameter (LVIDd) by cardiac echocardiography during follow-up.

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China