STAREE-HEART Sub-study Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Monash University
- Enrollment
- 369
- Locations
- 2
- Primary Endpoint
- Global longitudinal strain (GLS) measured via transthoracic echocardiography.
Study Overview
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 (myocardial dysfunction). 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 an ancillary 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 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 myocardial function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women aged ≥70 years living independently in the community who are participants in the STAREE RCT and eligible for randomisation to study medication.
- •Willing and able to provide informed consent and accept the STAREE-HEART study requirements, including attendance for an echocardiogram and undertaking home monitoring via ECG.
Exclusion Criteria
- •Known atrial fibrillation or atrial flutter.
- •Participants who do not wish to be informed of an abnormality under any circumstances, regardless of severity, will not be enrolled in the study.
Arms & Interventions
STAREE Placebo group
Participants in STAREE trial randomised to placebo
Intervention: Echocardiography (Diagnostic Test)
STAREE Placebo group
Participants in STAREE trial randomised to placebo
Intervention: ECG screening (Diagnostic Test)
STAREE Statin group
Participants in STAREE trial randomised to statin
Intervention: Echocardiography (Diagnostic Test)
STAREE Statin group
Participants in STAREE trial randomised to statin
Intervention: ECG screening (Diagnostic Test)
Outcomes
Primary Outcomes
Global longitudinal strain (GLS) measured via transthoracic echocardiography.
Time Frame: 3 years
Change in global longitudinal strain.
Secondary Outcomes
- Atrial fibrillation (AF) measured via single lead handheld ECG recordings.(3 years)
- Wavelet analysis via 12-lead ECG with Energy Waveform displays.(3 years)
Investigators
Ingrid Hopper
Principal Investigator
Monash University