RecruitingPhase 2Phase 3NCT05961202
The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy
The Efficacy and Mechanism of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy After Myocarditis
Sponsor
Tongji Hospital
Enrollment
200 participants
Start Date
Nov 1, 2021
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria8
- Male or female patient aged from 18 to 80 years;
- Left ventricular dysfunction \[left ventricular ejection fraction (LVEF) <50%\] diagnosed by echocardiography (Simpson's biplane) within 30 days before randomization;
- Chronic heart failure (lasting >6 months) unresponsive to conventional supportive therapy;
- High-sensitivity cardiac Troponin I (hs-cTnI) >26.2 pg/mL and N-terminal-pro-B-type natriuretic peptide (NT-proBNP) >169pg/mL;
- Suffered from confirmed fulminant myocarditis in the past;
- Diagnosed with chronic inflammatory cardiomyopathy confirmed by myocardial biopsy1;
- Absence of cardiotropic viruses at polymerase chain reaction analysis;
- Volunteer for the study and written informed consent;
Exclusion Criteria13
- Age <18 or >80 years;
- Acute myocardial infarction occurred within the past month;
- Subjects who have undergone cardiac surgery or cerebrovascular accidents within 6 months;
- Preparing for heart transplantation;
- With malignant arrhythmias such as long QT syndrome;
- Pregnancy or lactation;
- Have participated in any drug clinical trial within the three months;
- 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).
- Confirmed or possible systemic inflammatory diseases;
- On the brink of death or life expectancy of less than 1 year;
- Drug or alcohol abuse;
- cannot persist in taking medication due to various reasons;
- Inability to provide informed consent.
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Interventions
DRUGHydroxychloroquine
Hydroxychloroquine 200mg qd
DRUGPrednisolone
Prednisolone 20mg qd
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05961202
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