NCT04536870

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

STAREE-HEART Sub-study Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Monash University · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Failure
• Atrial Fibrillation
• Healthy Ageing
• Hypercholesterolemia
• Myocardial Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiography	Ultrasound of heart
DIAGNOSTIC_TEST	ECG screening	Single lead ECG screening twice daily for two weeks
DIAGNOSTIC_TEST	ECG Screening	12-lead ECG screening

Timeline

• Start date: 2019-12-12
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-09-03
• Last updated: 2025-04-02

Locations

2 sites across 1 country: Australia