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

Not Applicable

Active, not recruiting

• Conditions: Heart Failure; Atrial Fibrillation; Healthy Ageing; Hypercholesterolemia; Myocardial Dysfunction
• Interventions: Diagnostic Test: Echocardiography; Diagnostic Test: ECG Screening

• Registration Number: NCT04536870
• Lead Sponsor: Monash University

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 Timeline

• Study Start: 2019-12-12
• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 369

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STAREE Statin group	ECG Screening	Participants in STAREE trial randomised to statin
STAREE Placebo group	Echocardiography	Participants in STAREE trial randomised to placebo
STAREE Placebo group	ECG Screening	Participants in STAREE trial randomised to placebo
STAREE Statin group	Echocardiography	Participants in STAREE trial randomised to statin

Primary Outcome Measures

Name	Time	Method
Global longitudinal strain (GLS) measured via transthoracic echocardiography.	3 years	Change in global longitudinal strain.

Secondary Outcome Measures

Name	Time	Method
Atrial fibrillation (AF) measured via single lead handheld ECG recordings.	3 years	Development of new AF.
Wavelet analysis via 12-lead ECG with Energy Waveform displays.	3 years	Increases detection of Heart Failure (HF).

Trial Locations

Locations (2)

Curtin University; 🇦🇺 Perth, Western Australia, Australia

Monash University; School of Public Health and Preventative Medicine: STAREE trial; 🇦🇺 Melbourne, Victoria, Australia