Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04536870




Registration number
NCT04536870
Ethics application status
Date submitted
25/08/2020
Date registered
3/09/2020
Date last updated
27/07/2023

Titles & IDs
Public title
Statins in Reducing Events in the Elderly (STAREE) Heart Sub-study
Scientific title
STAREE-HEART Sub-study Clinical Trial
Secondary ID [1] 0 0
APP1165440
Universal Trial Number (UTN)
Trial acronym
STAREE-HEART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Atrial Fibrillation 0 0
Healthy Ageing 0 0
Hypercholesterolemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Echocardiography
Diagnosis / Prognosis - ECG screening
Diagnosis / Prognosis - ECG Screening

Experimental: STAREE Statin group - Participants in STAREE trial randomised to statin

Experimental: STAREE Placebo group - Participants in STAREE trial randomised to placebo


Diagnosis / Prognosis: Echocardiography
Ultrasound of heart

Diagnosis / Prognosis: ECG screening
Single lead ECG screening twice daily for two weeks

Diagnosis / Prognosis: ECG Screening
12-lead ECG screening
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Global longitudinal strain (GLS) measured via transthoracic echocardiography.
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
Atrial fibrillation (AF) measured via single lead handheld ECG recordings.
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
Wavelet analysis via 12-lead ECG with Energy Waveform displays.
Timepoint [1] 0 0
3 years

Eligibility
Key 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.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
Accrual to date
Final
364
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University; School of Public Health and Preventative Medicine: STAREE trial - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04536870
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ingrid Hopper
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04536870