Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04536870

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Dyslipidemias Healthy Ageing Heart Diseases Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Dysfunction Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash University; School of Public Health and Preventative Medicine: STAREE trial, Melbourne, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echocardiography

Diagnostic Test

Ultrasound of heart

Other names: Global longitudinal strain

ECG screening

Diagnostic Test

Single lead ECG screening twice daily for two weeks

Other names: Alivecor

Primary outcomes

  1. Global longitudinal strain (GLS) measured via transthoracic echocardiography.

    Time frame: 3 years

    Change in global longitudinal strain.

Secondary outcomes

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

    Time frame: 3 years

    Development of new AF.

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

    Time frame: 3 years

    Increases detection of Heart Failure (HF).

Other outcomes

  1. Atrial strain

    Time frame: Baseline to 3 year

    On echocardiography

  2. N- Terminal-pro-Brain Natriuretic Peptide (NT pro BNP)

    Time frame: Baseline to 3 year

    Predictor of heart failure

  3. Vascular Endothelial Growth Factor (VEG-F)

    Time frame: Baseline to 3 year

    Endothelial marker

  4. Intercellular Adhesion Molecule 1 (ICAM-1)

    Time frame: Baseline to 3 year

    Endothelial marker

  5. C-reactive protein

    Time frame: Baseline to 3 year

    Inflammatory biomarker

  6. Interleukin-6

    Time frame: Baseline to 3 year

    Inflammatory biomarker

  7. Tumour Necrosis Factor alpha (TNF alpha)

    Time frame: Baseline to 3 year

    Inflammatory biomarker

  8. Matrix metalloproteinase-9 (MMP-9)

    Time frame: Baseline to 3 year

    Fibrosis marker

  9. Tumour-derived protein tissue inhibitor of metalloproteinases-1 (TIMP-1)

    Time frame: Baseline to 3 year

    Fibrosis marker

  10. C-telopeptide of type I collagen (CTX I)

    Time frame: Baseline to 3 year

    Fibrosis marker

  11. Procollagen III N-terminal propeptide (PIIINP).

    Time frame: Baseline to 3 year

    Fibrosis marker

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • Curtin University
  • National Health and Medical Research Council, Australia

Registry information

Official study title

STAREE-HEART Sub-study Clinical Trial

Acronym: STAREE-HEART

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2020
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.