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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
| Curtin University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAREE Statin group | Experimental | Participants in STAREE trial randomised to statin |
|
| STAREE Placebo group | Experimental | Participants in STAREE trial randomised to placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Diagnostic Test | Ultrasound of heart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global longitudinal strain (GLS) measured via transthoracic echocardiography. | Change in global longitudinal strain. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation (AF) measured via single lead handheld ECG recordings. | Development of new AF. | 3 years |
| Wavelet analysis via 12-lead ECG with Energy Waveform displays. | Increases detection of Heart Failure (HF). |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial strain | On echocardiography | Baseline to 3 year |
| N- Terminal-pro-Brain Natriuretic Peptide (NT pro BNP) | Predictor of heart failure | Baseline to 3 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid Hopper | Monash University | Principal Investigator |
| Sophia Zoungas, MBBS PhD FRACP | Monash University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash University; School of Public Health and Preventative Medicine: STAREE trial | Melbourne | Victoria | 3004 | Australia | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40516583 | Derived | 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. |
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On completion of the trial, and after publication of the primary and secondary outcomes of the study, requests for access to de-identified data (to be provided through a secure online environment) may be submitted to the researchers located at the School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001281 | Atrial Fibrillation |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D000094582 | Global Longitudinal Strain |
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| ECG screening | Diagnostic Test | Single lead ECG screening twice daily for two weeks |
|
|
| ECG Screening | Diagnostic Test | 12-lead ECG screening |
|
|
| 3 years |
| Vascular Endothelial Growth Factor (VEG-F) | Endothelial marker | Baseline to 3 year |
| Intercellular Adhesion Molecule 1 (ICAM-1) | Endothelial marker | Baseline to 3 year |
| C-reactive protein | Inflammatory biomarker | Baseline to 3 year |
| Interleukin-6 | Inflammatory biomarker | Baseline to 3 year |
| Tumour Necrosis Factor alpha (TNF alpha) | Inflammatory biomarker | Baseline to 3 year |
| Matrix metalloproteinase-9 (MMP-9) | Fibrosis marker | Baseline to 3 year |
| Tumour-derived protein tissue inhibitor of metalloproteinases-1 (TIMP-1) | Fibrosis marker | Baseline to 3 year |
| C-telopeptide of type I collagen (CTX I) | Fibrosis marker | Baseline to 3 year |
| Procollagen III N-terminal propeptide (PIIINP). | Fibrosis marker | Baseline to 3 year |
| Curtin University |
| Perth |
| Western Australia |
| Australia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D004568 | Electrodiagnosis |