Viewing Study NCT04649294


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Study NCT ID: NCT04649294
Status: COMPLETED
Last Update Posted: 2020-12-02
First Post: 2020-10-24
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: The Effect of High Dose Glucocorticoid Steroids on Myocardial Function
Sponsor: Hillel Yaffe Medical Center
Organization:

Study Overview

Official Title: The Effect of High Dose Glucocorticoid Steroids on Myocardial Function
Status: COMPLETED
Status Verified Date: 2020-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: