The Effects of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy

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

Detailed Description
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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).

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

Conditions
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Inflammatory Cardiomyopathy, Myocarditis

Intervention / Treatment
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* Drug: Hydroxychloroquine
* Drug: Prednisolone


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCQ group<br>Hydroxychloroquine 200mg bid and Prednisolone 15mg qd for a long time (more than 1 year) | Drug: Hydroxychloroquine<br>* Hydroxychloroquine 200mg bid<br>Drug: Prednisolone<br>* Prednisolone 15mg qd<br>|
| Active Comparator: GC group<br>Prednisolone 15mg qd for a long time (more than 1 year) | Drug: Prednisolone<br>* Prednisolone 15mg qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The increase and dynamic changes of LVEF (%) | Measurement of left ventricular ejection fraction (LVEF) by cardiac echocardiography during follow-up. | 3 years | 
| The decrease and dynamic changes of hs-cTnI (pg/mL) |  | 3 years | 
| The decrease and dynamic changes of NT-proBNP (pg/mL) |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory cardiomyopathy, Myocarditis, Hydroxychloroquine, Randomized controlled trial