Back to resultsOutcome of Steroid Therapy for Myocardial Inflammation in Scleroderma
Primary Purpose
Myocardial Inflammation
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Prednisolone and taper
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Inflammation
Eligibility Criteria
Inclusion Criteria:
• The adult scleroderma patients who were defined as having myocardial inflammation by cardiac MRI.
Exclusion Criteria:
- Current infection that needs systemic antibiotic therapy
- Active viral hepatitis B or C
- Uncontrolled diabetes mellitus
Sites / Locations
- Department of Medicine, Faculty of Medicine, Khon Kaen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prednisolone
Arm Description
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.
Outcomes
Primary Outcome Measures
Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03607071
Brief Title
Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma
Official Title
Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Moderate dose steroid therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisolone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone and taper
Other Intervention Name(s)
Moderate steroid therapy
Intervention Description
Prednisolone 30 mg/d and taper 5-10 mg per 2 weeks until off at week 24.
Primary Outcome Measure Information:
Title
Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline
Description
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
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• The adult scleroderma patients who were defined as having myocardial inflammation by cardiac MRI.
Exclusion Criteria:
Current infection that needs systemic antibiotic therapy
Active viral hepatitis B or C
Uncontrolled diabetes mellitus
Facility Information:
Facility Name
Department of Medicine, Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33414828
Citation
Pussadhamma B, Tipparot T, Chaosuwannakit N, Mahakkanukrauh A, Suwannaroj S, Nanagara R, Foocharoen C. Clinical Outcomes of Myocarditis after Moderate-Dose Steroid Therapy in Systemic Sclerosis: A Pilot Study. Int J Rheumatol. 2020 Dec 19;2020:8884442. doi: 10.1155/2020/8884442. eCollection 2020.
Results Reference
derived
Learn more about this trial
Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma
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