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

NCT ID: NCT04536870

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2026-12-31

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 (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

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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

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Heart Failure Atrial Fibrillation Healthy Ageing Hypercholesterolemia Myocardial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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STAREE Statin group

Participants in STAREE trial randomised to statin

Group Type EXPERIMENTAL

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Ultrasound of heart

ECG screening

Intervention Type DIAGNOSTIC_TEST

Single lead ECG screening twice daily for two weeks

ECG Screening

Intervention Type DIAGNOSTIC_TEST

12-lead ECG screening

STAREE Placebo group

Participants in STAREE trial randomised to placebo

Group Type EXPERIMENTAL

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Ultrasound of heart

ECG screening

Intervention Type DIAGNOSTIC_TEST

Single lead ECG screening twice daily for two weeks

ECG Screening

Intervention Type DIAGNOSTIC_TEST

12-lead ECG screening

Interventions

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Echocardiography

Ultrasound of heart

Intervention Type DIAGNOSTIC_TEST

ECG screening

Single lead ECG screening twice daily for two weeks

Intervention Type DIAGNOSTIC_TEST

ECG Screening

12-lead ECG screening

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Global longitudinal strain Alivecor 12-lead ECG

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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Curtin University

OTHER

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role lead

Responsible Party

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Ingrid Hopper

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ingrid Hopper

Role: PRINCIPAL_INVESTIGATOR

Monash University

Sophia Zoungas, MBBS PhD FRACP

Role: STUDY_CHAIR

Monash University

Locations

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Monash University; School of Public Health and Preventative Medicine: STAREE trial

Melbourne, Victoria, Australia

Site Status

Curtin University

Perth, Western Australia, Australia

Site Status

Countries

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Australia

References

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Hopper I, Marwick TH, Wolfe R, Amerena J, Curtis AJ, Freedman B, Green DJ, Kaye D, Kolomoisky A, McNeil JJ, Nelson MR, Reid CM, Spark S, Tonkin AM, Wang BH, Zhou Z, Zoungas S. STAREE-HEART: A randomized placebo-controlled trial of atorvastatin effects on a marker of cardiac aging in older individuals without prior cardiovascular disease events: Protocol and baseline description of participants. Am Heart J. 2025 Dec;290:140-152. doi: 10.1016/j.ahj.2025.06.004. Epub 2025 Jun 12.

Reference Type DERIVED
PMID: 40516583 (View on PubMed)

Other Identifiers

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APP1165440

Identifier Type: -

Identifier Source: org_study_id

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