Hydroxychloroquine for Inflammatory Cardiomyopathy
The Effects of Hydroxychloroquine in Patients with Inflammatory Cardiomyopathy
Recruiting
Phase 2Phase 3Interventional Study
Inflammatory CardiomyopathyMyocarditis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Tongji Hospital · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 80 with inflammatory cardiomyopathy and heart failure. Participants will receive hydroxychloroquine to see how it compares to standard treatment.
Are You a Good Fit for This Trial?
Rules you outAcute myocardial infarctionMalignant arrhythmiasSystemic inflammatory diseasesDrug or alcohol abuse
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with inflammatory cardiomyopathy.
I have left ventricular dysfunction with an ejection fraction below 50%.
I have chronic heart failure lasting more than 6 months.
My cardiac Troponin I and NT-proBNP levels are elevated.
I have had confirmed fulminant myocarditis in the past.
I am willing to participate and provide informed consent.
You may not be able to join if
I am under 18 or over 80 years old.
I have had a heart attack in the past month.
I have had cardiac surgery or a stroke in the past 6 months.
I am preparing for a heart transplant.
I am pregnant or breastfeeding.
I have participated in another drug trial in the past 3 months.
I have certain health issues that would prevent me from taking hydroxychloroquine.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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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) unresponsi…
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.
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