STAREE-HEART Sub-study Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 369
- 试验地点
- 2
- 主要终点
- Global longitudinal strain (GLS) measured via transthoracic echocardiography.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
STAREE Placebo group
Participants in STAREE trial randomised to placebo
干预措施: Echocardiography (Diagnostic Test)
STAREE Placebo group
Participants in STAREE trial randomised to placebo
干预措施: ECG screening (Diagnostic Test)
STAREE Statin group
Participants in STAREE trial randomised to statin
干预措施: Echocardiography (Diagnostic Test)
STAREE Statin group
Participants in STAREE trial randomised to statin
干预措施: ECG screening (Diagnostic Test)
结局指标
主要结局
Global longitudinal strain (GLS) measured via transthoracic echocardiography.
时间窗: 3 years
Change in global longitudinal strain.
次要结局
- Atrial fibrillation (AF) measured via single lead handheld ECG recordings.(3 years)
- Wavelet analysis via 12-lead ECG with Energy Waveform displays.(3 years)
研究者
Ingrid Hopper
Principal Investigator
Monash University