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
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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