RecruitingNAINTERVENTIONAL

CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)

Heart failure is a serious condition, and fluid build-up (called congestion) is a major problem, often leading to hospital visits. Even people who feel okay can have hidden fluid issues that could worsen their heart failure later. This study aims to find better ways to detect and measure this fluid build-up in people with chronic heart failure where the heart struggles to pump blood effectively. We're using a mix of regular check-ups, special blood tests, and ultrasound scans to look for clear signs. The main goal is to identify which of these signs best predict the risk of hospitalisation, needing strong medicines for fluid, or even death, helping doctors better manage heart failure and improve patients' lives.

At a glance

Status

Recruiting

Phase

Sponsor

Pr. Nicolas GIRERD

Enrolment target

200

Start

14 Dec 2021

Estimated completion

14 Jun 2029

Chronic Heart Failure Reduced Ventricular Ejection Fraction

What is this study about?

Heart failure is a common and serious condition, especially in older adults, where the heart can't pump enough blood around the body. One of the biggest problems for people with heart failure is fluid building up, often in the lungs, legs, or belly. This fluid build-up, called congestion, is the main reason people feel unwell and often end up in hospital.

Even when someone with heart failure feels okay, they might still have hidden fluid build-up that could cause problems later. Currently, doctors use different methods to check for this fluid. This study, called CHF-COV Reduced, wants to find out which of these methods – including careful examinations, specific blood tests, and detailed ultrasound scans – are best at finding and tracking this fluid build-up in people with a specific type of heart failure where the heart's main pumping chamber isn't working as well as it should.

The main aim is to discover clear indicators or 'markers' that can predict someone's risk of having to go into hospital for their heart failure, needing strong medication to remove fluid, or other serious outcomes. By finding better ways to spot and measure congestion, doctors hope to manage heart failure more effectively, keep people healthier, and reduce the need for hospital stays.

Key takeaways

Heart failure congestion often leads to hospital visits.
This study aims to find better ways to detect fluid build-up.
It uses exams, blood tests, and ultrasound scans.
The goal is to improve management and predict risks.
It focuses on a type of heart failure where the heart struggles to pump.

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 chamber is weaker than normal (doctors call this 'reduced left ventricular ejection fraction'). You might be considered if you're coming in for a scheduled hospital visit or a clinic appointment. You also need to understand the study and agree to take part by signing a consent form.

However, there are reasons you might not be able to join. For instance, if you have another serious health condition that means you're not expected to live more than three months, or if you're on kidney dialysis or have very severe kidney problems. People with certain severe lung conditions that would make ultrasound scans difficult, or those who are pregnant or breastfeeding, also can't take part.

Finally, if you're under certain legal protections or are unable to give consent yourself, you wouldn't be able to join this study.

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?
Do you have chronic heart failure with a weaker pumping heart?
Are you able to understand and sign a consent form?
Are you NOT pregnant or breastfeeding?
Do you NOT have severe kidney problems requiring dialysis?
Do you NOT have severe lung disease that would make lung scans difficult?

Answer every question to see your result.

What does participation involve?

If you join this study, the research team will regularly check for signs of fluid build-up. This will involve physical examinations, where doctors will look for swelling or listen to your heart and lungs. You'll also have special ultrasound scans of your heart, lungs, tummy, and the veins in your neck. These scans help doctors see if there's any hidden fluid. Blood samples will be taken for various tests and to be stored for future research. You will also have follow-up phone calls and complete a questionnaire (called the Kansas City Cardiomyopathy Questionnaire) about how your symptoms affect your daily life. The study doesn't mention specific medication changes, but focuses on assessments. The total duration of your participation will depend on the study's follow-up plan, which will be explained to you.

Potential risks and benefits

Participating in this study might help doctors learn more about managing heart failure, which could benefit you and others in the future. You will also receive very close monitoring of your heart condition. The assessments, like blood tests and ultrasounds, are generally safe procedures. However, there are minor risks, such as discomfort or bruising from blood draws. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What is 'congestion' in heart failure?

Congestion means there's too much fluid building up in your body, often in your lungs, legs, or belly, because your heart isn't pumping effectively.

How will the study check for fluid build-up?

Doctors will use physical exams, blood tests, and special ultrasound scans of your heart, lungs, and other areas to look for fluid.

Will I have to stay in hospital for the study?

The study involves assessments during scheduled clinic visits or day hospitalisation, not necessarily an overnight stay.

What does 'reduced ejection fraction' mean?

It means your heart's main pumping chamber isn't squeezing as strongly as it should to push blood out to your body.

Will this study change my current heart failure treatment?

The study focuses on assessing fluid build-up, not directly changing your existing medication, but information gained could help guide future treatment decisions.

How to find out more

Nicolas GIRERD, MD, PhD

n.girerd@chru-nancy.fr 0033383157322 Official trial record

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