The Effect of High Dose Glucocorticoid Steroids on Myocardial Function

High-dose Steroids, Myocardial Function, Longitudinal Strain Clinical Trial

Official title:

The Effect of High Dose Glucocorticoid Steroids on Myocardial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649294
• Other study ID #: 0052-17
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: October 2020
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Long term steroid exposure, as in Cushing's disease, causes myocardial dysfunction, hypertrophy and fibrosis in addition to causing obesity, hypertension and glucose intolerance. The aim of our study was to verify if short-term high-dose exogenous steroid therapy adversely effects the heart.

Description:

Patients eligible for high dose steroid therapy due to inflammatory diseases were offered to participate in this study. The minimal total intravenous dose was 375 mg prednisone, and the daily steroids were divided into 2-3 doses. To determine the steroids' effect on myocardial function the echocardiographic studies included estimation of global and segmental longitudinal strain. Each patient had a baseline echocardiographic study performed before high-dose steroid therapy was initiated and again immediately after it. A follow-up echo study was performed after completion of a 3-month low-dose steroid therapy period. The paired 2-tailed t-test was used to compare group means

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 20, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18

• Patient with rheumatic disease that need high dose steroids due to exacerbation

• Patient whom echocardiographic study can be performed with a good quality

Exclusion Criteria:

• age below 18

Related Conditions & MeSH terms

• High-dose Steroids, Myocardial Function, Longitudinal Strain
• Sprains and Strains

Locations

Country	Name	City	State
Israel	Hillel Yaffe Hospital	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine the steroids' effect on myocardial function the echocardiographic studies included estimation of global and segmental longitudinal strain	the aim of the study was to verify if the reported adverse effect of long-term endogenous cortisol excess on LV systolic and diastolic function occurs after short-term, high-dose, exogenous steroid therapy as well.Patients with inflammatory diseases in internal medicine department who needed treatment with high dose steroids recruited to the study baseline echocardiographic study performed before high-dose steroid therapy was initiated. A second study was performed after completion of the high-dose protocol and scheduled for a third echocardiographic study after completion of a 3-month low-dose steroid therapy period or immediately after termination of steroid therapy if it was during the 3-month period . global and segmental longitudinal strain measured by echo in addition to standard echo measures .the aim to see if high dose steroids use accompanied by echocardiographic changes as seen in Cushing disease	two years