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

March 26, 2025 updated by: Ingrid Hopper, Monash University

STAREE-HEART Sub-study Clinical Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

369

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Monash University; School of Public Health and Preventative Medicine: STAREE trial
    • Western Australia
      • Perth, Western Australia, Australia
        • Curtin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STAREE Statin group
Participants in STAREE trial randomised to statin
Diagnostic test: Echocardiography
Ultrasound of heart
Other Names:
  • Global longitudinal strain
Diagnostic test: ECG screening
Single lead ECG screening twice daily for two weeks
Other Names:
  • Alivecor
Experimental: STAREE Placebo group
Participants in STAREE trial randomised to placebo
Diagnostic test: Echocardiography
Ultrasound of heart
Other Names:
  • Global longitudinal strain
Diagnostic test: ECG screening
Single lead ECG screening twice daily for two weeks
Other Names:
  • Alivecor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global longitudinal strain (GLS) measured via transthoracic echocardiography.
Time Frame: 3 years
Change in global longitudinal strain.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation (AF) measured via single lead handheld ECG recordings.
Time Frame: 3 years
Development of new AF.
3 years
Wavelet analysis via 12-lead ECG with Energy Waveform displays.
Time Frame: 3 years
Increases detection of Heart Failure (HF).
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial strain
Time Frame: Baseline to 3 year
On echocardiography
Baseline to 3 year
N- Terminal-pro-Brain Natriuretic Peptide (NT pro BNP)
Time Frame: Baseline to 3 year
Predictor of heart failure
Baseline to 3 year
Vascular Endothelial Growth Factor (VEG-F)
Time Frame: Baseline to 3 year
Endothelial marker
Baseline to 3 year
Intercellular Adhesion Molecule 1 (ICAM-1)
Time Frame: Baseline to 3 year
Endothelial marker
Baseline to 3 year
C-reactive protein
Time Frame: Baseline to 3 year
Inflammatory biomarker
Baseline to 3 year
Interleukin-6
Time Frame: Baseline to 3 year
Inflammatory biomarker
Baseline to 3 year
Tumour Necrosis Factor alpha (TNF alpha)
Time Frame: Baseline to 3 year
Inflammatory biomarker
Baseline to 3 year
Matrix metalloproteinase-9 (MMP-9)
Time Frame: Baseline to 3 year
Fibrosis marker
Baseline to 3 year
Tumour-derived protein tissue inhibitor of metalloproteinases-1 (TIMP-1)
Time Frame: Baseline to 3 year
Fibrosis marker
Baseline to 3 year
C-telopeptide of type I collagen (CTX I)
Time Frame: Baseline to 3 year
Fibrosis marker
Baseline to 3 year
Procollagen III N-terminal propeptide (PIIINP).
Time Frame: Baseline to 3 year
Fibrosis marker
Baseline to 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Collaborators

National Health and Medical Research Council, Australia
Curtin University

Investigators

  • Principal Investigator: Ingrid Hopper, Monash University
  • Study Chair: Sophia Zoungas, MBBS PhD FRACP, Monash University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APP1165440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

On completion of the trial, and after publication of the primary and secondary outcomes of the study, requests for access to de-identified data (to be provided through a secure online environment) may be submitted to the researchers located at the School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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