Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04536870
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2020-08-25
Brief Title:
Statins in Reducing Events in the Elderly STAREE Heart Sub-study
Sponsor:
Monash University
Organization:
Monash University
Study Overview
Official Title:
STAREE-HEART Sub-study Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
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:
STAREE-HEART
Brief Summary:
The STAREE-HEART sub-study will examine the effect of statin treatment over a 3-year period compared with placebo on markers of cardiac ageing This will include determining global longitudinal strain with transthoracic echocardiography atrial fibrillation with home measures twice daily for two weeks and changes in biomarkers
Detailed Description:
STAREE-HEART is a sub-study nested in the Statins in Reducing Events in the Elderly STAREE double-blind randomised placebo-controlled trial STAREE is investigating whether statins can prolong good health and maintain independence amongst older people and is enrolling men and women 70 years of age and over who are free from cardiovascular disease diabetes and dementia STAREE-HEART will recruit a subset of 1000 STAREE participants before they are randomised to STAREE study drug STAREE-HEART will involve an additional suite of cardiac assessments in these participants and will provide detailed information about the clinical effect of statins on incidence of atrial fibrillation and heart failure
Study Oversight
Has Oversight DMC:
None
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?:
None