RecruitingOBSERVATIONAL

The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme

The SALTIRE Programme is a study investigating aortic stenosis, a common heart valve disease where the main outflow valve of the heart becomes stiff and narrow. The goal is to better understand what makes this condition develop and progress, and how it affects people after they've had their valve replaced. We're inviting people with different stages of aortic stenosis, those who've had valve replacements, and healthy volunteers to participate. Participants will have regular check-ups, blood tests, and advanced imaging scans like PET-CT and MRI. These scans use special dyes to help us see things like inflammation, scarring, and calcium build-up in the heart. This information will help doctors learn more about the disease and potentially develop better treatments in the future.

At a glance

Status

Recruiting

Sponsor

University of Edinburgh

Enrolment target

300

Start

22 May 2023

Estimated completion

22 May 2028

Aortic Stenosis

What is this study about?

This study, called the Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme, is designed to help us learn more about aortic stenosis. This is a common heart condition where the main valve that lets blood leave your heart (the aortic valve) becomes stiff and doesn't open properly. This can make your heart work harder to pump blood around your body.

The main aim of this study is to understand why some people develop aortic stenosis, why it gets worse in some people faster than others, and what happens in the heart after someone has had their faulty valve replaced. By looking closely at these processes, we hope to find clues that could lead to better ways to treat or even prevent the disease in the future.

We will be using advanced scanning techniques and blood tests to monitor people over time. This includes looking at things like inflammation, scarring, and calcium build-up within the heart valve and surrounding areas. This kind of detailed information is crucial for doctors and researchers to get a clearer picture of this complex condition.

Key takeaways

Study looks at causes and progression of aortic stenosis.
No new medicines, only observations and tests.
Involves regular check-ups and advanced heart scans.
Lasts about four years with visits every six months.
Aims to improve future treatments for heart valve disease.
Your participation is voluntary and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be over 50 years old, male or female, and be able to understand and agree to take part. We are looking for different groups of people:

* People who have had a new aortic valve fitted, either through surgery or a keyhole procedure. * People with different levels of aortic stenosis, from mild (just starting) to moderate or severe (more advanced). * People who have been told they have 'aortic sclerosis', which means their heart valve is thickening but isn't yet significantly blocking blood flow.

We also need healthy volunteers of a similar age and gender to compare with those who have the heart condition. However, you can't join if you're unable to give informed consent, have specific allergies to dyes used in scans, have significant kidney problems, are pregnant or breastfeeding, or have certain rare heart conditions like Rheumatic Heart Disease, Ochronosis, or Familial Homozygous Hypercholesterolaemia.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 50 years old?
Do you have some form of aortic valve condition (like aortic stenosis, aortic sclerosis, or a valve replacement)?
Are you able to agree to take part after understanding the study?
Are you NOT pregnant or breastfeeding?
Do you NOT have serious kidney problems or specific allergies to scan dyes?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be part of it for about four years. You'll need to visit the Clinical Research Facility (CRF) for check-ups every six months. Each year, you'll have more detailed assessments. These will include a general health check, blood tests, and an ultrasound scan of your heart (called an echocardiogram). You'll also have more advanced scans, which might include CT, MRI, and PET scans. These special scans help us see detailed pictures of your heart and how it's working.

There are no new medications given as part of this study; it's purely about observation and gathering information. You are free to withdraw from the study at any time without explaining why, and it won't affect your normal medical care.

Potential risks and benefits

Taking part in this study could help us learn more about aortic stenosis, which may lead to better treatments for future patients. While there isn't a direct personal health benefit for you from participating, your contribution is valuable. There are some potential risks associated with the scans, such as exposure to small amounts of radiation from CT and PET scans, or reactions to the special dyes sometimes used (though these are rare). Blood tests carry a small risk of bruising. You can choose to leave the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Edinburgh
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is 'aortic stenosis'?

It's a heart condition where a main valve in your heart called the aortic valve becomes narrow, making your heart work harder.

What is the main goal of this study?

We want to understand what makes aortic stenosis develop and get worse, and what happens after a valve replacement.

How long will I be involved in the study?

The study lasts for about four years, with check-ups every six months.

Will I take any new medicines?

No, this study doesn't involve any new medicines. It's about observing and collecting information.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without giving a reason, and it won't affect your medical care.

How to find out more

Neil Craig

neil.craig@ed.ac.uk 07383558066 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.