The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy

Launched by TONGJI HOSPITAL · Jul 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called hydroxychloroquine in patients with inflammatory cardiomyopathy, a condition that affects the heart and can lead to heart failure. The goal is to see if hydroxychloroquine can provide long-term benefits and be safer compared to traditional glucocorticoid therapy alone. The trial is currently looking for participants between the ages of 18 and 80 who have specific heart-related issues, including significant heart weakness and a history of myocarditis (inflammation of the heart).

If you or a loved one decides to participate, you will be randomly assigned to receive either hydroxychloroquine or the glucocorticoid treatment. To be eligible, participants must have chronic heart failure that hasn't improved with regular treatments and meet certain health criteria. Before joining, you’ll need to provide informed consent and meet all the health guidelines outlined in the study. This trial is an important step in understanding how to better treat people with inflammatory cardiomyopathy, and your participation could help advance medical knowledge in this area.

Gender

ALL

Eligibility criteria

• 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.