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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    500
  • sponsor
    Monash University
Updated on 26 January 2021
electrocardiogram
diagnostic procedure
fibrillation
12 lead ECG
heart study
hmg-coa reductase inhibitors

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.

Description

STAREE-HEART is a sub-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 1000 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 incidence of atrial fibrillation and heart failure.

Details
Condition Hypercholesterolemia, Arrhythmia, Dysrhythmia, Arrhythmia, Atrial Fibrillation, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Heart failure, Congestive Heart Failure, Heart failure, Heart disease, Heart disease, Cardiac Disease, Hyperlipidemia, High Cholesterol (Hyperlipidemia), High Cholesterol (Hyperlipidemia), Atrial Fibrillation (Pediatric), Healthy Ageing, High Cholesterol, Congestive Heart Failure, Dysrhythmia, Cardiac Disease, elevated cholesterol, hypercholesteremia, cardiac failure, congestive heart disease
Treatment Echocardiography, ECG screening
Clinical Study IdentifierNCT04536870
SponsorMonash University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note