Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

Sponsor

Khon Kaen University (Other)

Overall Status

Completed

CT.gov ID

NCT03607071

Collaborator

(none)

Enrollment

Location

Arm

13.5

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Inflammation	Drug: Prednisolone and taper	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Moderate dose steroid therapyModerate dose steroid therapy

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prednisolone 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 Names: Moderate steroid therapy

Arm

Intervention/Treatment

Experimental: Prednisolone

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 Names:

Moderate steroid therapy

Outcome Measures

Primary Outcome Measures

Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medicine, Faculty of Medicine, Khon Kaen University	Khon Kaen		Thailand	40002

Sponsors and Collaborators

Khon Kaen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chingching Foocharoen, Principle investigator, Khon Kaen University

ClinicalTrials.gov Identifier:

NCT03607071

Other Study ID Numbers:

SSc-KKU

First Posted:

Jul 31, 2018

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocarditis

Inflammation

Prednisolone

Study Results

No Results Posted as of Sep 9, 2020