The Efficacy and Mechanism of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy After Myocarditis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Dao Wen Wang, MD, PhD
dwwang@tjh.tjmu.edu.cn
+86-027-6937-8422
Backup
Wu He
hewu0912@163.com
+8613972334305
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 200
Treatments
Experimental: HCQ group
Hydroxychloroquine 200mg qd and Prednisolone 20mg qd for 12 months
Active_comparator: Non-HCQ group
Prednisolone 20mg qd for 12 months
Related Therapeutic Areas
Sponsors
Leads: Tongji Hospital
Collaborators: Wuhan Central Hospital, Taihe Hospital

This content was sourced from clinicaltrials.gov

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