Phase
Condition
Cardiomyopathy
Chest Pain
Dermatomyositis (Connective Tissue Disease)
Treatment
Prednisolone
Hydroxychloroquine
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
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 beforerandomization;
Chronic heart failure (lasting >6 months) unresponsive to conventional supportivetherapy;
High-sensitivity cardiac Troponin I (hs-cTnI) >26.2 pg/mL and N-terminal-pro-B-typenatriuretic 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;
Exclusion
Exclusion criteria:
Age <18 or >80 years;
Acute myocardial infarction occurred within the past month;
Subjects who have undergone cardiac surgery or cerebrovascular accidents within 6months;
Preparing for heart transplantation;
With malignant arrhythmias such as long QT syndrome;
Pregnancy or lactation;
Have participated in any drug clinical trial within the three months;
Presence of contraindications to prednisolone and/or hydroxychloroquine (includinghypersensitivity to prednisone or hydroxychloroquine, mainly untreated systemicinfection, 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 < 11g/dL).
Confirmed or possible systemic inflammatory diseases;
On the brink of death or life expectancy of less than 1 year;
Drug or alcohol abuse;
cannot persist in taking medication due to various reasons;
Inability to provide informed consent.
Study Design
Study Description
Connect with a study center
Tongji Hospital
Wuhan, Hubei 430030
ChinaActive - Recruiting
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