The Effect of High Dose Glucocorticoid Steroids on Myocardial Function

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.

Study Overview

• Status: Completed
• Conditions: High-dose Steroids, Myocardial Function, Longitudinal Strain

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel
    • Hillel Yaffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient with inflammatory disease who needs high dose steroids according to there disease severity and welling to participate in observation study to see the effect od steroids taken on the myocaridal functions duering hospital stay

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: October 24, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 0052-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No