Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

Khon Kaen University

Status and phase: Completed; Phase 2

Conditions: Myocardial Inflammation

Treatments: Drug: Prednisolone and taper

Study type: Interventional

Funder types: Other

Identifiers

NCT03607071

SSc-KKU

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Prednisolone

Experimental group

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.

Treatment:

Drug: Prednisolone and taper