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

Primary Purpose

Heart Failure, Atrial Fibrillation, Healthy Ageing

Status

Active

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Echocardiography

ECG screening

ECG Screening

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Statin, Atorvastatin, STAREE, Echocardiography, Atrial fibrillation screening, Global longitudinal strain, Single time point screening, Elderly

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Monash University; School of Public Health and Preventative Medicine: STAREE trial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

STAREE Statin group

STAREE Placebo group

Arm Description

Participants in STAREE trial randomised to statin

Participants in STAREE trial randomised to placebo

Outcomes

Primary Outcome Measures

Global longitudinal strain (GLS) measured via transthoracic echocardiography.

Change in global longitudinal strain.

Atrial fibrillation (AF) measured via single lead handheld ECG recordings.

Development of new AF.

Secondary Outcome Measures

Wavelet analysis via 12-lead ECG with Energy Waveform displays.

Increases detection of Heart Failure (HF).

Full Information

NCT ID

NCT04536870

First Posted

August 25, 2020

Last Updated

July 24, 2023

Sponsor

Monash University

Collaborators

National Health and Medical Research Council, Australia

1. Study Identification

Unique Protocol Identification Number

NCT04536870

Brief Title

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

Acronym

STAREE-HEART

Official Title

STAREE-HEART Sub-study Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 12, 2019 (Actual)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Monash University

Collaborators

National Health and Medical Research Council, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Atrial Fibrillation, Healthy Ageing, Hypercholesterolemia

Keywords

Statin, Atorvastatin, STAREE, Echocardiography, Atrial fibrillation screening, Global longitudinal strain, Single time point screening, Elderly

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

364 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STAREE Statin group

Arm Type

Experimental

Arm Description

Participants in STAREE trial randomised to statin

Arm Title

STAREE Placebo group

Arm Type

Experimental

Arm Description

Participants in STAREE trial randomised to placebo

Intervention Type

Diagnostic Test

Intervention Name(s)

Echocardiography

Other Intervention Name(s)

Global longitudinal strain

Intervention Description

Ultrasound of heart

Intervention Type

Diagnostic Test

Intervention Name(s)

ECG screening

Other Intervention Name(s)

Alivecor

Intervention Description

Single lead ECG screening twice daily for two weeks

Intervention Type

Diagnostic Test

Intervention Name(s)

ECG Screening

Other Intervention Name(s)

12-lead ECG

Intervention Description

12-lead ECG screening

Primary Outcome Measure Information:

Title

Global longitudinal strain (GLS) measured via transthoracic echocardiography.

Description

Change in global longitudinal strain.

Time Frame

3 years

Title

Atrial fibrillation (AF) measured via single lead handheld ECG recordings.

Description

Development of new AF.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Wavelet analysis via 12-lead ECG with Energy Waveform displays.

Description

Increases detection of Heart Failure (HF).

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ingrid Hopper

Organizational Affiliation

Monash University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Monash University; School of Public Health and Preventative Medicine: STAREE trial

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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