The Effect of High Dose Glucocorticoid Steroids on Myocardial Function

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04649294
Collaborator
(none)
23
1
18.6
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    23 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of High Dose Glucocorticoid Steroids on Myocardial Function
    Actual Study Start Date :
    Jun 1, 2017
    Actual Primary Completion Date :
    Jun 1, 2018
    Actual Study Completion Date :
    Dec 20, 2018

    Outcome Measures

    Primary Outcome Measures

    1. determine the steroids' effect on myocardial function the echocardiographic studies included estimation of global and segmental longitudinal strain [two years]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hillel Yaffe Hospital Hadera Israel

    Sponsors and Collaborators

    • Hillel Yaffe Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hillel Yaffe Medical Center
    ClinicalTrials.gov Identifier:
    NCT04649294
    Other Study ID Numbers:
    • 0052-17
    First Posted:
    Dec 2, 2020
    Last Update Posted:
    Dec 2, 2020
    Last Verified:
    Oct 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2020