Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma
- Registration Number
- NCT03607071
- Lead Sponsor
- Khon Kaen University
- Brief Summary
Primary myocardial involvement is common in scleroderma, effected to pericardium, vascular, conducting defect and especially myocardium. Cardiac MRI is widely used for assessment of cardiac involvement in scleroderma, both structural and functional pathology. Cardiac MRI has a diagnostic accuracy of 85% for the detection of myocardial inflammation. Nowadays, the treatment of myocardial inflammation in scleroderma is uncertain. The investigator's study aims to define the cardiac outcome after moderate dose steroid therapy in the patients who have myocardial inflammation detection by cardiac MRI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
• The adult scleroderma patients who were defined as having myocardial inflammation by cardiac MRI.
- Current infection that needs systemic antibiotic therapy
- Active viral hepatitis B or C
- Uncontrolled diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prednisolone Prednisolone and taper The patient who has detected myocardial inflammation from cardiac MRI from baseline is given prednisolone 30 mg/d and taper 5-10 mg per 2 weeks until off at week 24.
- Primary Outcome Measures
Name Time Method Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline 24 weeks Myocarditis is defined as inflammatory disease of the myocardium according to the cardiac MRI Lake Louise criteria at least 2 of the following criteria:
1. Regional or global myocardial signal intensity increased in the T2-weighted images;
2. Increased global myocardial early enhancement ratio between the myocardium and skeletal muscle in the gadolinium-enhanced T1-weighted images; and,
3. At least 1 focal lesion with nonischemic regional distribution in the inversion-recovery-prepared, gadolinium-enhanced, T1-weighted images (delayed enhancement).
Response to treatment is defined as any reducing of degree of myocarditis without any progression of myocardial fibrosis or scarring when compared to the cardiac MRI baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Medicine, Faculty of Medicine, Khon Kaen University
🇹🇭Khon Kaen, Thailand