NCT05961202 The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy
| NCT ID | NCT05961202 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Tongji Hospital |
| Condition | Inflammatory Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2024-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2021-11-01 with a primary completion date of 2024-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05961202 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Inflammatory Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05961202 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05961202 currently recruiting?
Yes, NCT05961202 is actively recruiting participants. Contact the research team at dwwang@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT05961202 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05961202 clinical trial?
NCT05961202 is sponsored by Tongji Hospital. The trial plans to enroll 200 participants.