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

Study Overview
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Brief Summary
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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
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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.

Official Title
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STAREE-HEART Sub-study Clinical Trial

Conditions
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Heart Failure, Atrial Fibrillation, Healthy Ageing, Hypercholesterolemia

Intervention / Treatment
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* Diagnostic Test: Echocardiography
* Diagnostic Test: ECG screening
* Diagnostic Test: ECG Screening


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STAREE Statin group<br>Participants in STAREE trial randomised to statin | Diagnostic Test: Echocardiography<br>* Ultrasound of heart<br>* Other names: Global longitudinal strain;Diagnostic Test: ECG screening<br>* Single lead ECG screening twice daily for two weeks<br>* Other names: Alivecor;Diagnostic Test: ECG Screening<br>* 12-lead ECG screening<br>* Other names: 12-lead ECG;|
| Experimental: STAREE Placebo group<br>Participants in STAREE trial randomised to placebo | Diagnostic Test: Echocardiography<br>* Ultrasound of heart<br>* Other names: Global longitudinal strain;Diagnostic Test: ECG screening<br>* Single lead ECG screening twice daily for two weeks<br>* Other names: Alivecor;Diagnostic Test: ECG Screening<br>* 12-lead ECG screening<br>* Other names: 12-lead ECG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global longitudinal strain (GLS) measured via transthoracic echocardiography. | Change in global longitudinal strain. | 3 years | 
| Atrial fibrillation (AF) measured via single lead handheld ECG recordings. | Development of new AF. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wavelet analysis via 12-lead ECG with Energy Waveform displays. | Increases detection of Heart Failure (HF). | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statin, Atorvastatin, STAREE, Echocardiography, Atrial fibrillation screening, Global longitudinal strain, Single time point screening, Elderly