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

NCT04536870 | Active Not Recruiting

• 1 other identifier: APP1165440
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Statin; Atorvastatin; STAREE; Echocardiography; Atrial fibrillation screening; Global longitudinal strain; Single time point screening; Elderly

Outcome Measures

Primary Outcomes (1)

• Global longitudinal strain (GLS) measured via transthoracic echocardiography.

  Change in global longitudinal strain.

  3 years

Secondary Outcomes (2)

• Atrial fibrillation (AF) measured via single lead handheld ECG recordings.

  3 years

• Wavelet analysis via 12-lead ECG with Energy Waveform displays.

  3 years

Other Outcomes (11)

• Atrial strain

  Baseline to 3 year

• N- Terminal-pro-Brain Natriuretic Peptide (NT pro BNP)

  Baseline to 3 year

• Vascular Endothelial Growth Factor (VEG-F)

  Baseline to 3 year

Study Arms (2)

STAREE Statin group

EXPERIMENTAL

Participants in STAREE trial randomised to statin

Diagnostic Test: Echocardiography; Diagnostic Test: ECG screening

STAREE Placebo group

EXPERIMENTAL

Participants in STAREE trial randomised to placebo

Diagnostic Test: Echocardiography; Diagnostic Test: ECG screening

Interventions

Echocardiography DIAGNOSTIC_TEST

Ultrasound of heart

Also known as: Global longitudinal strain

STAREE Placebo group; STAREE Statin group

ECG Screening DIAGNOSTIC_TEST

Single lead ECG screening twice daily for two weeks

Also known as: Alivecor

STAREE Placebo group; STAREE Statin group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Monash University: lead
• National Health and Medical Research Council, Australia: collaborator
• Curtin University: collaborator

Study Sites (2)

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

Melbourne, Victoria, 3004, Australia

Location

Curtin University

Perth, Western Australia, Australia

Location

Related Publications (1)

• 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.

  PMID: 40516583 DERIVED

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation; Hypercholesterolemia

Interventions

Echocardiography; Global Longitudinal Strain; Electrocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Electrodiagnosis

Study Officials

• Ingrid Hopper

  Monash University

  PRINCIPAL INVESTIGATOR

• Sophia Zoungas, MBBS PhD FRACP

  Monash University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 3, 2020
• Study Start: December 12, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)