The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2025-11-01

Brief Summary

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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

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

Conditions

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Inflammatory Cardiomyopathy Myocarditis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HCQ group

Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine 200mg qd

Prednisolone

Intervention Type DRUG

Prednisolone 20mg qd

Non-HCQ group

Prednisolone 20mg qd for 12 months

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Prednisolone 20mg qd

Interventions

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Hydroxychloroquine

Hydroxychloroquine 200mg qd

Intervention Type DRUG

Prednisolone

Prednisolone 20mg qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female patient aged from 18 to 80 years;
2. Left ventricular dysfunction \[left ventricular ejection fraction (LVEF) \<50%\] diagnosed by echocardiography (Simpson's biplane) within 30 days before randomization;
3. Chronic heart failure (lasting \>6 months) unresponsive to conventional supportive therapy;
4. High-sensitivity cardiac Troponin I (hs-cTnI) \>26.2 pg/mL and N-terminal-pro-B-type natriuretic peptide (NT-proBNP) \>169pg/mL;
5. Suffered from confirmed fulminant myocarditis in the past;
6. Diagnosed with chronic inflammatory cardiomyopathy confirmed by myocardial biopsy1;
7. Absence of cardiotropic viruses at polymerase chain reaction analysis;
8. Volunteer for the study and written informed consent;

Exclusion Criteria

1. Age \<18 or \>80 years;
2. Acute myocardial infarction occurred within the past month;
3. Subjects who have undergone cardiac surgery or cerebrovascular accidents within 6 months;
4. Preparing for heart transplantation;
5. With malignant arrhythmias such as long QT syndrome;
6. Pregnancy or lactation;
7. Have participated in any drug clinical trial within the three months;
8. Presence of contraindications to prednisolone and/or hydroxychloroquine (including hypersensitivity to prednisone or hydroxychloroquine, mainly untreated systemic infection, uncontrolled diabetes, poorly controlled endocrine diseases, osteoporosis, gastric or duodenal ulcer, uncontrolled hypertension, leukocytopenia (leukocyte counts \< 4×109/L), neutropenia (neutrophils \< 1.5×109/L), thrombocytopenia (platelet levels \< 130×109/L), anemia (hemoglobin levels \< 11 g/dL).
9. Confirmed or possible systemic inflammatory diseases;
10. On the brink of death or life expectancy of less than 1 year;
11. Drug or alcohol abuse;
12. cannot persist in taking medication due to various reasons;
13. Inability to provide informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No