Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction
This research focuses on people with a heart condition called HFpEF (Heart Failure with preserved ejection fraction) where the heart struggles to pump blood effectively, and also have narrowed heart arteries. Doctors aren't sure if opening these arteries with small tubes called stents helps improve how people with HFpEF feel and their quality of life. This study, called REPRIEVED, aims to find out. Around 350 people will take part, with some receiving a stent and others a mock procedure. Participants won't know which they received initially. Over 6 months, researchers will track changes in their quality of life through questionnaires, blood tests, and heart scans to understand if stents make a difference.
At a glance
What is this study about?
Heart failure with preserved ejection fraction, or HFpEF, is a common condition where the heart muscle has become stiff. This means it can't relax properly or fill with enough blood, so it struggles to pump blood around your body, making you feel tired and out of breath. Many people with HFpEF also have coronary artery disease, which means the important blood vessels supplying oxygen to the heart muscle itself are narrowed or blocked.
At the moment, we don't know for sure if opening up these narrowed arteries with small mesh tubes called stents can help people with HFpEF feel better or improve their daily lives. This study, called REPRIEVED, aims to answer that important question. The researchers want to compare two groups of people: one group will have a stent fitted to open up their arteries, and the other group will have a 'placebo procedure'. This placebo procedure feels just like having a stent fitted but doesn't actually involve placing a stent.
By comparing these groups, the researchers hope to understand if the stent treatment genuinely improves quality of life for people living with both HFpEF and coronary artery disease, or if any improvements are due to other factors. This research could help doctors deliver better care and treatments for this specific group of patients in the future.
Key takeaways
- This study investigates if heart stents improve quality of life for people with both HFpEF and narrowed heart arteries.
- Around 350 participants will receive either a real stent or a mock procedure, without knowing which one.
- Participation involves initial tests, the procedure day, and follow-up assessments at 3 and 6 months.
- Your contribution is vital for understanding future treatments for HFpEF.
- You can withdraw from the study at any time.
- Potential risks involved are explained before you consent to take part.
Who may be eligible?
To join this study, you would need to be an adult (18 years or older) and have received a diagnosis of HFpEF, based on specific medical guidelines. This includes having symptoms like shortness of breath and tiredness, along with certain heart measurements from tests like blood tests and heart scans.
There are also some reasons why you might not be able to join. For example, if you've recently had a heart attack or another heart procedure in the last three months, or if placing a stent isn't suitable for you based on special scans of your heart. You also wouldn't be able to take part if you have certain other serious health conditions, particularly severe lung disease or specific other heart problems that might explain your HFpEF. Additionally, if you're taking part in another study that might affect the results of this one, you wouldn't be eligible.
The research team would check all these details carefully with you and your medical records to make sure the study is right and safe for you.
- Are you 18 years old or older?
- Have you been diagnosed with HFpEF by your doctor?
- Do you also have evidence of narrowed heart arteries?
- Have you had a heart attack or other heart procedure in the last 3 months?
- Do you have certain serious lung or other heart conditions?
- Are you able to take anti-clotting medication?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, your journey will start with some initial assessments. These include filling out a health questionnaire, having a blood test, an electrocardiogram (which records your heart's electrical activity), and scans of your heart. These tests help ensure you're suitable for the study and provide a starting point for comparing changes later.
On the day of your procedure, you'll come into the hospital for a procedure called an angiogram. At this point, you'll be randomly chosen to either receive a heart stent or a placebo procedure, which feels the same but doesn't involve a stent. You won't know which procedure you've had until the end of the study. This is important to make sure we truly understand the effects of the stent itself.
After your procedure, a research team member will keep in touch. At 3 months, you'll complete a short health questionnaire, either over the phone or during a hospital visit. At 6 months, you'll return to the hospital for a final check-up. This will involve another health questionnaire, blood tests, and repeat heart scans (echocardiogram and electrocardiogram) to see if and how your heart has changed. At the end of the 6 months, you'll be told whether you received the stent or the placebo procedure.
Potential risks and benefits
Locations (1)
- Guy's & St Thomas' NHS Foundation TrustLondon, United Kingdom· Recruiting
Common questions
What is HFpEF?
HFpEF is a type of heart failure where your heart muscle becomes stiff, making it harder for your heart to fill with blood and pump it effectively, leading to symptoms like breathlessness.
What is a stent?
A stent is a tiny mesh tube that doctors can place in a narrowed or blocked artery to help keep it open and improve blood flow.
Why won't I know if I got a stent?
Not knowing whether you received a stent or a placebo procedure helps researchers determine if any improvements in your quality of life are truly due to the stent and not just because you think you've had the treatment. This makes the results more reliable.
How long will I be involved in the study?
You will be monitored for a total of 6 months after your procedure, with check-ups at 3 months and a final visit at 6 months.
Can I leave the study at any time?
Yes, you are completely free to leave the study at any point without it affecting your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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