HYPIC: The Effects of Hydroxychloroquine in Patients With Inflammatory Cardiomyopathy

Sponsor

Tongji Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05961202

Collaborator

Wuhan Central Hospital (Other), Taihe Hospital (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Cardiomyopathy Myocarditis	Drug: Hydroxychloroquine Drug: Prednisolone	Phase 2/Phase 3

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 (6, 12, 18, 24, 36 months).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HCQ group Hydroxychloroquine 200mg bid and Prednisolone 15mg qd for a long time (more than 1 year)	Drug: Hydroxychloroquine Hydroxychloroquine 200mg bid Drug: Prednisolone Prednisolone 15mg qd
Active Comparator: GC group Prednisolone 15mg qd for a long time (more than 1 year)	Drug: Prednisolone Prednisolone 15mg qd

Arm

Intervention/Treatment

Experimental: HCQ group

Hydroxychloroquine 200mg bid and Prednisolone 15mg qd for a long time (more than 1 year)

Drug: Hydroxychloroquine

Hydroxychloroquine 200mg bid

Drug: Prednisolone

Prednisolone 15mg qd

Active Comparator: GC group

Prednisolone 15mg qd for a long time (more than 1 year)

Drug: Prednisolone

Prednisolone 15mg qd

Outcome Measures

Primary Outcome Measures

Composite incidence of cardiovascular death or heart transplant [3 years]
Cardiovascular death was defined as death from cardiovascular causes and any unknown death unless there was another certain cause.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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；