RecruitingNAINTERVENTIONAL

Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation

This study focuses on chronic heart failure, a common and serious condition, particularly in older adults. Many people with heart failure experience fluid build-up, known as congestion, even when their heart's main pumping action is preserved. This congestion often leads to symptoms and hospital stays. Researchers are investigating various tests – including physical exams, blood and urine tests, and different types of ultrasound scans – to identify the best ways to spot and monitor this fluid build-up. The main goal is to discover which of these markers (signs) can best predict future health issues, such as needing to be hospitalised for heart failure, requiring special medication given through an IV, or even death. This research aims to improve how doctors keep an eye on and treat patients with this type of heart failure.

At a glance

Status

Recruiting

Phase

Sponsor

Central Hospital, Nancy, France

Enrolment target

200

Start

10 Aug 2022

Estimated completion

10 Jun 2029

Chronic Heart Failure Preserved Ejection Fraction

What is this study about?

When your heart doesn't pump blood as well as it should, it's called heart failure. This can lead to various problems, and one of the most common is a build-up of fluid in the body, which doctors call congestion. This fluid build-up can make you feel tired, breathless, or swollen, and it's a big reason why people with heart failure might need to go to the hospital, especially if they are over 65.

Interestingly, some people have a type of heart failure where their heart still pumps blood quite well, but they still get this fluid build-up. Even if they don't have many symptoms, signs of fluid build-up can mean bigger problems are coming. Doctors currently use different ways to check for this, like physical exams, blood tests, and ultrasound scans. This study wants to see which of these ways, or perhaps a combination, is the best at telling us about a person's future health.

The main purpose of this study is to identify specific signs – whether from a simple check-up, blood tests, or ultrasound pictures – that can help doctors keep a closer eye on people with this kind of heart failure. We want to find out which of these signs are most linked to important future events, such as needing an urgent hospital visit for heart failure, needing strong medication through a drip, or sadly, even death. By finding better ways to spot and track fluid build-up, we hope to improve care for people living with chronic heart failure.

Key takeaways

Study focused on better monitoring chronic heart failure with preserved pumping ability.
Investigates fluid build-up (congestion) using various tests.
Aims to find best predictors for hospitalisation or other serious events.
Involves physical exams, blood/urine tests, and ultrasound scans.
Participation includes phone follow-ups and questionnaires.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) with chronic heart failure where your heart's main pumping action is still mostly working well (doctors call this 'preserved ejection fraction'). You would typically be coming in for a scheduled check-up or a day visit at the hospital. You must also understand the study well and agree to take part by signing a consent form. Being part of the UK social security scheme is also a requirement.

There are certain reasons why you might not be able to join. For example, if you have another serious illness that doctors expect will shorten your life greatly (less than 3 months), or if you are on dialysis for kidney failure, or have very severe kidney problems. People who have had certain severe lung surgeries or have serious lung conditions that would interfere with ultrasound scans also can't take part. Pregnant or breastfeeding women, or those unable to give consent for legal reasons, also won't be able to participate.

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 or older?
Do you have chronic heart failure where your heart still pumps well?
Are you able to agree to take part and sign a consent form?
Are you affiliated with the UK social security system?
Are you not currently on dialysis or do you have very severe kidney failure?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a special clinical examination focusing on fluid build-up in your body. This will include doing several types of ultrasound scans. These scans will look at your heart, lungs, tummy area (peritoneal), the veins in your neck (jugular), and your kidneys. You will also have a special test called liver elastography, which checks the stiffness of your liver. Additionally, you will be asked to provide blood and urine samples for various tests and for future research.

You will also have a telephone follow-up. This is where researchers will call you to check in on how you're doing. You will also fill out a questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ), which asks about your symptoms and how heart failure affects your daily life. The total duration of your participation will depend on the study's follow-up schedule, which will be explained in detail when you consider joining.

Potential risks and benefits

Participating in this study might benefit you by providing a very thorough medical evaluation and close monitoring of your heart condition. It also contributes valuable information that could help improve care for many other people with heart failure in the future. As with any medical procedure, there are minimal risks involved with blood draws (e.g., bruising) and urine collection (minor discomfort). Ultrasound scans are generally very safe and painless. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHRU de Nancy
Verified postcode
Vandœuvre-lès-Nancy, France· Recruiting

Common questions

What is 'preserved ejection fraction'?

It means your heart's main pumping chamber is still pushing out a good amount of blood with each beat, even though you have heart failure.

What is 'congestion'?

Congestion means there's too much fluid building up in your body, which can make you feel breathless, tired, or cause swelling.

Will I have to take new medication?

No, this study is about monitoring your condition, not about testing new medications.

How long will I be in the study?

The study involves a consultation or day hospital visit, with some follow-up calls, but the total duration will be explained to you in detail.

Are the ultrasound scans painful?

No, ultrasound scans are generally pain-free and use sound waves, not radiation.

How to find out more

Nicolas GIRERD, MD, PhD

n.girerd@chru-nancy.fr + 33 3 83 15 73 22 Official trial record

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