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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04536870
Other study ID # APP1165440
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 12, 2019
Est. completion date December 2026

Study information

Verified date July 2023
Source Monash University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. This will include determining global longitudinal strain with transthoracic echocardiography, atrial fibrillation with home measures twice daily for two weeks and changes in biomarkers.


Description:

STAREE-HEART is a sub-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 1000 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 incidence of atrial fibrillation and heart failure.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 364
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Echocardiography
Ultrasound of heart
ECG screening
Single lead ECG screening twice daily for two weeks
ECG Screening
12-lead ECG screening

Locations

Country Name City State
Australia Monash University; School of Public Health and Preventative Medicine: STAREE trial Melbourne Victoria

Sponsors (2)

Lead Sponsor Collaborator
Monash University National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global longitudinal strain (GLS) measured via transthoracic echocardiography. Change in global longitudinal strain. 3 years
Primary Atrial fibrillation (AF) measured via single lead handheld ECG recordings. Development of new AF. 3 years
Secondary Wavelet analysis via 12-lead ECG with Energy Waveform displays. Increases detection of Heart Failure (HF). 3 years
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