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Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03607071
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Chingching Foocharoen, Khon Kaen University

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Moderate 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 : June 30, 2019
Actual Study Completion Date : June 30, 2019


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 Name: Moderate steroid therapy




Primary Outcome Measures :
  1. 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:

    1. Regional or global myocardial signal intensity increased in the T2-weighted images;
    2. Increased global myocardial early enhancement ratio between the myocardium and skeletal muscle in the gadolinium-enhanced T1-weighted images; and,
    3. 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607071


Locations
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Thailand
Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chingching Foocharoen, Principle investigator, Khon Kaen University
ClinicalTrials.gov Identifier: NCT03607071    
Other Study ID Numbers: SSc-KKU
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocarditis
Inflammation
Pathologic Processes
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents