Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

Myocardial Inflammation Clinical Trial

Official title:

Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607071
• Other study ID #: SSc-KKU
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2020
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Myocardial Inflammation
• Myocarditis

Intervention

Drug:
• Prednisolone and taper
Prednisolone 30 mg/d and taper 5-10 mg per 2 weeks until off at week 24.

Locations

Country	Name	City	State
Thailand	Department of Medicine, Faculty of Medicine, Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks