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โ† Trials
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The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy

RecruitingPhase 2, Phase 3Ages 18 Years - 80 YearsAllTongji Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 \< 4ร—109/L), neutropenia (neutrophils \< 1.5ร—109/L), thrombocytopenia (platelet levels \< 130ร—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.
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What it tests

  • Hydroxychloroquine
  • Prednisolone
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Where

1 site
Tongji Hospital
Wuhan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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