Clinical trial NCT04536870: Statins in Reducing Events in the Elderly (STAREE) Heart Sub-study
Official title: STAREE-HEART Sub-study Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: Curtin University
First posted: 2020-09-03
Enrollment: 369
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (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.

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.

Primary outcomes:
measure: Global longitudinal strain (GLS) measured via transthoracic echocardiography.
timeFrame: 3 years
Secondary outcomes:
measure: Atrial fibrillation (AF) measured via single lead handheld ECG recordings.
timeFrame: 3 years
measure: Wavelet analysis via 12-lead ECG with Energy Waveform displays.
timeFrame: 3 years
Other outcomes:
measure: Atrial strain
timeFrame: Baseline to 3 year
measure: N- Terminal-pro-Brain Natriuretic Peptide (NT pro BNP)
timeFrame: Baseline to 3 year
measure: Vascular Endothelial Growth Factor (VEG-F)
timeFrame: Baseline to 3 year
measure: Intercellular Adhesion Molecule 1 (ICAM-1)
timeFrame: Baseline to 3 year
measure: C-reactive protein
timeFrame: Baseline to 3 year
measure: Interleukin-6
timeFrame: Baseline to 3 year
measure: Tumour Necrosis Factor alpha (TNF alpha)
timeFrame: Baseline to 3 year
measure: Matrix metalloproteinase-9 (MMP-9)
timeFrame: Baseline to 3 year
measure: Tumour-derived protein tissue inhibitor of metalloproteinases-1 (TIMP-1)
timeFrame: Baseline to 3 year
measure: C-telopeptide of type I collagen (CTX I)
timeFrame: Baseline to 3 year
measure: Procollagen III N-terminal propeptide (PIIINP).
timeFrame: Baseline to 3 year
Locations:
city: Melbourne
country: Australia
facility: Monash University; School of Public Health and Preventative Medicine: STAREE trial
state: Victoria
city: Perth
country: Australia
facility: Curtin University
state: Western Australia
Study officials:
affiliation: Monash University
name: Ingrid Hopper
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: Sophia Zoungas, MBBS PhD FRACP
role: STUDY_CHAIR
References: