Actively Recruiting
The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy
Led by Tongji Hospital · Updated on 2024-10-09
200
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
W
Wuhan Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient aged from 18 to 80 years
- Left ventricular dysfunction (left ventricular ejection fraction [LVEF] <50%) diagnosed by echocardiography within 30 days before randomization
- Chronic heart failure lasting more than 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
- History of confirmed fulminant myocarditis
- Diagnosis of chronic inflammatory cardiomyopathy confirmed by myocardial biopsy
- Absence of cardiotropic viruses at polymerase chain reaction analysis
- Voluntary participation with written informed consent
You will not qualify if you...
- Age less than 18 or greater than 80 years
- Acute myocardial infarction within the past month
- Cardiac surgery or cerebrovascular accident within the past 6 months
- Preparing for heart transplantation
- Presence of malignant arrhythmias such as long QT syndrome
- Pregnancy or lactation
- Participation in another drug clinical trial within the last three months
- Contraindications to prednisolone or hydroxychloroquine including hypersensitivity, untreated systemic infection, uncontrolled diabetes or endocrine diseases, osteoporosis, gastric or duodenal ulcer, uncontrolled hypertension, low white blood cell counts, neutropenia, thrombocytopenia, or anemia
- Confirmed or possible systemic inflammatory diseases
- Life expectancy less than 1 year or being on the brink of death
- Drug or alcohol abuse
- Inability to continue medication for various reasons
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
D
Dao Wen Wang, MD, PhD
CONTACT
W
Wu He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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