Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma
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|ClinicalTrials.gov Identifier: NCT03607071|
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Inflammation||Drug: Prednisolone and taper||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Moderate dose steroid therapy|
|Masking:||None (Open Label)|
|Official Title:||Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study|
|Actual Study Start Date :||May 15, 2018|
|Actual Primary Completion Date :||June 30, 2019|
|Actual Study Completion Date :||June 30, 2019|
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.
Drug: Prednisolone and taper
Prednisolone 30 mg/d and taper 5-10 mg per 2 weeks until off at week 24.
Other Name: Moderate steroid therapy
- Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline [ Time Frame: 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:
- Regional or global myocardial signal intensity increased in the T2-weighted images;
- Increased global myocardial early enhancement ratio between the myocardium and skeletal muscle in the gadolinium-enhanced T1-weighted images; and,
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607071
|Department of Medicine, Faculty of Medicine, Khon Kaen University|
|Khon Kaen, Thailand, 40002|