The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy
Recruiting now · Phase 2/Phase 3
Conditions studied: Inflammatory Cardiomyopathy, Myocarditis
In brief
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
Key facts
- Study ID
- NCT05961202
- Run by
- Tongji Hospital
- People needed
- 200
- Starts
- 2021-11-01
- Expected to finish
- 2025-11-01
- Last updated by the study team
- 2024-10-09
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- Tongji Hospital — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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