Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

NCT ID: NCT03607071

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Moderate dose steroid therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Prednisolone and taper

Intervention Type DRUG

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

Interventions

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Prednisolone and taper

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

Intervention Type DRUG

Other Intervention Names

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Moderate steroid therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Chingching Foocharoen

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Medicine, Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Site Status

Countries

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Thailand

References

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Pussadhamma B, Tipparot T, Chaosuwannakit N, Mahakkanukrauh A, Suwannaroj S, Nanagara R, Foocharoen C. Clinical Outcomes of Myocarditis after Moderate-Dose Steroid Therapy in Systemic Sclerosis: A Pilot Study. Int J Rheumatol. 2020 Dec 19;2020:8884442. doi: 10.1155/2020/8884442. eCollection 2020.

Reference Type DERIVED
PMID: 33414828 (View on PubMed)

Other Identifiers

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SSc-KKU

Identifier Type: -

Identifier Source: org_study_id

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