Atrial Fibrillation, Healthy Ageing, Heart Failure, Hypercholesterolemia, Myocardial Dysfunction
Conditions
Keywords
Statin, Atorvastatin, STAREE, Echocardiography, Atrial fibrillation screening, Global longitudinal strain, Single time point screening, Elderly
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.
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.
Interventions
DIAGNOSTIC_TESTEchocardiography
Ultrasound of heart
DIAGNOSTIC_TESTECG screening
Single lead ECG screening twice daily for two weeks
DIAGNOSTIC_TESTECG Screening
12-lead ECG screening
Sponsors
National Health and Medical Research Council, Australia
Curtin University
Monash University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global longitudinal strain (GLS) measured via transthoracic echocardiography. | 3 years | Change in global longitudinal strain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation (AF) measured via single lead handheld ECG recordings. | 3 years | Development of new AF. |
| Wavelet analysis via 12-lead ECG with Energy Waveform displays. | 3 years | Increases detection of Heart Failure (HF). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intercellular Adhesion Molecule 1 (ICAM-1) | Baseline to 3 year | Endothelial marker |
| C-reactive protein | Baseline to 3 year | Inflammatory biomarker |
| Interleukin-6 | Baseline to 3 year | Inflammatory biomarker |
| Tumour Necrosis Factor alpha (TNF alpha) | Baseline to 3 year | Inflammatory biomarker |
| Atrial strain | Baseline to 3 year | On echocardiography |
| Tumour-derived protein tissue inhibitor of metalloproteinases-1 (TIMP-1) | Baseline to 3 year | Fibrosis marker |
| C-telopeptide of type I collagen (CTX I) | Baseline to 3 year | Fibrosis marker |
| Procollagen III N-terminal propeptide (PIIINP). | Baseline to 3 year | Fibrosis marker |
| Matrix metalloproteinase-9 (MMP-9) | Baseline to 3 year | Fibrosis marker |
| N- Terminal-pro-Brain Natriuretic Peptide (NT pro BNP) | Baseline to 3 year | Predictor of heart failure |
| Vascular Endothelial Growth Factor (VEG-F) | Baseline to 3 year | Endothelial marker |
Countries
Australia
Outcome results
None listed