Statins in Reducing Events in the Elderly (STAREE) Heart Sub-study (STAREE-HEART)

Monash University

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Myocardial Dysfunction; Hypercholesterolemia; Heart Failure; Healthy Ageing

Treatments: Diagnostic Test: ECG Screening; Diagnostic Test: Echocardiography; Diagnostic Test: ECG screening

Study type: Interventional

Funder types: Other

Identifiers

NCT04536870

APP1165440

Details and patient eligibility

About

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.

Full 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.

Enrollment: 369 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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369 participants in 2 patient groups

STAREE Statin group

Experimental group

Description:

Participants in STAREE trial randomised to statin

Treatment:

Diagnostic Test: ECG screening

Diagnostic Test: Echocardiography

STAREE Placebo group

Experimental group

Description:

Participants in STAREE trial randomised to placebo

Treatment:

Diagnostic Test: ECG screening

Diagnostic Test: Echocardiography