Effects of Hydroxychloroquine on Inflammatory Cardiomyopathy
The Efficacy and Mechanism of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy After Myocarditis
This study is testing if adding hydroxychloroquine to standard treatment can help people with inflammatory cardiomyopathy feel better and improve their heart function.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05961202 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the long-term therapeutic effects and safety of hydroxychloroquine compared to glucocorticoid therapy alone in patients with inflammatory cardiomyopathy, a condition often leading to heart failure. Patients with chronic heart failure and left ventricular dysfunction will be randomly assigned to receive either hydroxychloroquine combined with glucocorticoids or glucocorticoids alone. The study aims to measure clinical benefits through improvements in left ventricular ejection fraction and reductions in specific cardiac biomarkers over a follow-up period of up to 36 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with chronic inflammatory cardiomyopathy and left ventricular dysfunction unresponsive to standard treatments.
Not a fit: Patients with acute myocardial infarction, recent cardiac surgery, or those preparing for heart transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from inflammatory cardiomyopathy, potentially improving heart function and overall prognosis.
How similar studies have performed: While hydroxychloroquine has shown promise in treating other inflammatory conditions, this specific application in inflammatory cardiomyopathy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Dao Wen Wang, MD, PhD
- Email: dwwang@tjh.tjmu.edu.cn
- Phone: +86-027-6937-8422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.