RecruitingInterventional

Coronary artery stents in heart failure with preserved ejection fraction

Heart failure with preserved ejection fraction (HFpEF) is a condition where the heart struggles to pump blood effectively, making people feel tired and breathless. Many people with HFpEF also have blocked heart arteries. This study aims to find out if placing small metal tubes, called stents, into these blocked arteries can improve the health and quality of life for people with HFpEF. Stents are commonly used for other heart problems and are generally safe. Participants will be randomly assigned to either receive a stent procedure or a mock procedure to help researchers understand if this treatment is truly beneficial. The study will help us learn more about the best ways to treat HFpEF.

At a glance

Status

Recruiting

Enrolment target

350

Start

23 Mar 2026

Estimated completion

31 May 2028

Heart failure with preserved ejection fraction (HFpEF) and coronary artery disease

What is this study about?

Heart failure with preserved ejection fraction (HFpEF) is a medical condition where your heart muscle becomes stiff, making it difficult for your heart to fill properly with blood. This means it can't pump enough blood around your body to meet its needs. Common symptoms include feeling breathless, very tired, and having swollen legs. HFpEF often affects people with other health problems like high blood pressure, diabetes, kidney issues, and obesity, and it tends to be more common in women and certain ethnic groups. Unfortunately, there aren't many treatments specifically for HFpEF.

About half of all people with HFpEF also have blocked blood vessels that supply blood to their heart, known as coronary artery disease. These blockages might be a key reason why their heart failure developed. Stents are tiny metal tubes that doctors can put into these blocked arteries during a keyhole operation. They work by opening up the vessels, allowing blood to flow normally again. We know stents are effective and safe for other heart conditions like heart attacks and angina, but we don't yet know if they help people with HFpEF.

This study, called REPRIEVED, wants to find out if giving people with HFpEF and blocked heart arteries a stent procedure can improve their quality of life and the blood supply to their heart. Doctors, researchers, and patients are working together on this important study. The results will help us understand if this treatment could become a standard option for people living with HFpEF in the future.

Key takeaways

This study investigates if stents improve heart failure (HFpEF).
It targets people with both HFpEF and blocked heart arteries.
Participants will be randomly assigned to receive a stent or a mock procedure.
Results could lead to new treatments for HFpEF.
The study is a partnership between medical professionals and patients.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with two specific heart conditions: heart failure with preserved ejection fraction (HFpEF) and coronary artery disease. This means your heart has difficulty pumping blood effectively, and you also have blockages in the blood vessels that supply your heart.

There are also some reasons why you might not be able to join. For example, if you've recently had a heart attack or a similar heart procedure within the last three months, or if you're already taking part in another study that might affect the results of this one. You also can't take part if you have certain other serious health conditions, or if the stent procedure wouldn't be safe or possible for you.

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 18 years old or older?
Have you been diagnosed with Heart Failure with preserved ejection fraction (HFpEF)?
Do you also have blockages in your heart's blood vessels (coronary artery disease)?
Have you had a heart attack or similar heart procedure in the last 3 months?
Do you have severe lung disease (COPD GOLD stage 3 or worse)?
Are you able to give your informed consent to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups, like flipping a coin. You won't get to choose which group you're in, and neither will your doctor. One group will receive a procedure where a stent (a small tube) is placed in your heart's blood vessels to open them up. The other group will have a 'mock' procedure. This involves a thin tube going into your artery to examine it, but no actual stent will be put in. This 'mock' procedure helps us understand the true effect of the stent itself. You will also have various assessments and follow-up appointments. The study is expected to run from September 2024 to August 2029.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, because we don't yet know if stents truly help people with HFpEF, we can't promise that you will directly feel better. However, the information we gain will be incredibly valuable, potentially leading to better treatments for future patients with HFpEF. Risks include specific procedures like CT scans and angiograms, which involve small amounts of radiation and very small risks like minor bruising or, less commonly, more serious issues like bleeding, heart attack, or stroke. Having a stent placed carries slightly higher, but still small, risks of these complications. You will also take blood-thinning medication, which increases the risk of bleeding. It's important to remember that you can decide to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

St Thomas' Hospital
Approximate
London, England
King's College Hospital
Approximate
London, England
Royal Bournemouth Hospital
Approximate
Bournemouth, England
Mid and South Essex NHS Foundation Trust
City only
Westcliff-on-sea, England
Golden Jubilee National Hospital
Approximate
Clydebank, Scotland
St. Bartholomews Hospital
Unverified
London, England
Leeds General Infirmary
Unverified
Leeds, England
Freeman Road Hospital
Unverified
Newcastle upon Tyne, England

Common questions

What is HFpEF?

HFpEF stands for Heart Failure with preserved ejection fraction. It means your heart muscle is stiff, making it hard for it to fill with blood and pump it effectively around your body.

What is a stent?

A stent is a tiny metal tube placed inside a blocked heart artery to keep it open, allowing blood to flow more freely.

Will I know if I get a stent or the mock procedure?

No, you won't know which group you're in. This helps ensure the study results are fair and accurate.

Who is paying for this study?

The study is funded by the National Institute for Health Research (NIHR), a major UK health research funder.

How long will the study last?

The study is expected to run from September 2024 to August 2029.

How to find out more

Matthew Kwok

REPRIEVED@lshtm.ac.uk - Official trial record

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