Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

NCT03607071 | Completed Phase 2 DMC

• 1 other identifier: SSc-KKU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Inflammation

Outcome Measures

Primary Outcomes (1)

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

  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

  24 weeks

Study Arms (1)

Prednisolone

EXPERIMENTAL

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

Interventions

Prednisolone and taper DRUG

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

Also known as: Moderate steroid therapy

Prednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The adult scleroderma patients who were defined as having myocardial inflammation by cardiac MRI.

You may not qualify if:

• Current infection that needs systemic antibiotic therapy
• Active viral hepatitis B or C
• Uncontrolled diabetes mellitus

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Department of Medicine, Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• 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.

  PMID: 33414828 DERIVED

MeSH Terms

Conditions

Myocarditis

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Moderate dose steroid therapy

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: May 15, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

TH (1)