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

Heart Failure Clinical Trial

— STAREE-HEART  

Official title:

STAREE-HEART Sub-study Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04536870
• Other study ID #: APP1165440
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Healthy Ageing
• Heart Failure
• Hypercholesterolemia

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