Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

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.

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Key information

Conditions

Myocardial Inflammation Cardiomyopathies Cardiovascular Diseases Heart Diseases Myocarditis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Medicine, Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone and taper

Drug

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

Other names: Moderate steroid therapy

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jul 31, 2018
Registry last updated: Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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