Heart FailureSTAREE-HEARTNCT04536870
Statins in Reducing Events in the Elderly (STAREE) Heart Sub-study
A study testing Echocardiography and ECG screening in people with Heart Failure and Atrial Fibrillation, run by Monash University at 2 sites in Australia.
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 (myocardial dysfunction). This will include determining global longitudinal strain with transthoracic echocardiography, atrial fibrillation with home measures twice daily for… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Atrial Fibrillation, Healthy Ageing
- What is being tested?
- Echocardiography and ECG screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 2 sitesAustralia
- Study dates
- 12 Dec 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Monash University; School of Public Health and Preventative Medicine: STAREE trial
Melbourne, Victoria, 3004
Curtin University
Perth, Western Australia
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Atrial Fibrillation, Healthy Ageing, Hypercholesterolemia, Myocardial Dysfunction
- Being tested
- Echocardiography, ECG screening
- Keywords
- Statin, Atorvastatin, STAREE, Echocardiography, Atrial fibrillation screening, Global longitudinal strain, Single time point screening, Elderly
- Medical subject headings
- Heart Failure, Atrial Fibrillation, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Also called Global longitudinal strain
Ultrasound of heart
ECG screeningDiagnostic test
Also called Alivecor
Single lead ECG screening twice daily for two weeks
ECG ScreeningDiagnostic test
Also called 12-lead ECG
12-lead ECG screening
| Study group | Role | What they receive |
|---|---|---|
| STAREE Statin group | Experimental | Participants in STAREE trial randomised to statin Receives: Diagnostic Test: Echocardiography; Diagnostic Test: ECG screening |
| STAREE Placebo group | Experimental | Participants in STAREE trial randomised to placebo Receives: Diagnostic Test: Echocardiography; Diagnostic Test: ECG screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global longitudinal strain (GLS) measured via transthoracic echocardiography.
Change in global longitudinal strain.
Measured: 3 years
Secondary outcomes (2)
Atrial fibrillation (AF) measured via single lead handheld ECG recordings.
Development of new AF.
Measured: 3 years
Wavelet analysis via 12-lead ECG with Energy Waveform displays.
Increases detection of Heart Failure (HF).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start12 Dec 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Curtin University
- Responsible party
- Principal investigator, Ingrid Hopper, Monash University
- Investigators
- Ingrid Hopper, Principal investigator, Monash UniversitySophia Zoungas, MBBS PhD FRACP, Study chair, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536870
- Sponsor's protocol ID
- APP1165440
- Acronym
- STAREE-HEART
- Status last verified
- Mar 2025
- First submitted
- 25 Aug 2020
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Hopper I, Marwick TH, Wolfe R, Amerena J, Curtis AJ, Freedman B, Green DJ, Kaye D, Kolomoisky A, McNeil JJ, Nelson MR, Reid CM, Spark S, Tonkin AM, Wang BH, Zhou Z, Zoungas S. STAREE-HEART: A randomized placebo-controlled trial of atorvastatin effects on a marker of cardiac aging in older individuals without prior cardiovascular disease events: Protocol and baseline description of participants. Am Heart J. 2025 Dec;290:140-152. doi: 10.1016/j.ahj.2025.06.004. Epub 2025 Jun 12.
PubMed 40516583
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAREE-HEART Sub-study Clinical Trial
- ClinicalTrials.gov ID
- NCT04536870
- Acronym / sponsor ID
- STAREE-HEART / APP1165440
- Conditions
- Heart Failure, Atrial Fibrillation, Healthy Ageing, Hypercholesterolemia, Myocardial Dysfunction
- Keywords
- Statin, Atorvastatin, STAREE, Echocardiography, Atrial fibrillation screening, Global longitudinal strain, Single time point screening, Elderly
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Curtin University
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAREE Statin group | Experimental | Diagnostic Test: Echocardiography, Diagnostic Test: ECG screeningParticipants in STAREE trial randomised to statin |
| STAREE Placebo group | Experimental | Diagnostic Test: Echocardiography, Diagnostic Test: ECG screeningParticipants in STAREE trial randomised to placebo |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyAlso: Global longitudinal strainUltrasound of heart | Diagnostic test | STAREE Placebo group, STAREE Statin group |
| ECG screeningAlso: AlivecorSingle lead ECG screening twice daily for two weeks | Diagnostic test | STAREE Placebo group, STAREE Statin group |
| ECG ScreeningAlso: 12-lead ECG12-lead ECG screening | Diagnostic test | STAREE Placebo group, STAREE Statin group |
Primary outcome
Global longitudinal strain (GLS) measured via transthoracic echocardiography.
Time frame: 3 years
Change in global longitudinal strain.
2 secondary outcomes
Atrial fibrillation (AF) measured via single lead handheld ECG recordings.
Time frame: 3 years
Wavelet analysis via 12-lead ECG with Energy Waveform displays.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 40516583Hopper I, Marwick TH, Wolfe R, Amerena J, Curtis AJ, Freedman B, Green DJ, Kaye D, Kolomoisky A, McNeil JJ, Nelson MR, Reid CM, Spark S, Tonkin AM, Wang BH, Zhou Z, Zoungas S. STAREE-HEART: A randomized placebo-controlled trial of atorvastatin effects on a marker of cardiac aging in older individuals without prior cardiovascular disease events: Protocol and baseline description of participants. Am Heart J. 2025 Dec;290:140-152. doi: 10.1016/j.ahj.2025.06.004. Epub 2025 Jun 12.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Hopper principal investigator
Monash University
Sophia Zoungas, MBBS PhD FRACP study chair
Monash University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography and ECG screening in people with Heart Failure and Atrial Fibrillation, run by Monash University at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global longitudinal strain (GLS) measured via transthoracic echocardiography. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.