RecruitingNAINTERVENTIONAL

Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation

This study focuses on people admitted to hospital with a specific type of heart failure where the heart doesn't pump blood as strongly as it should (called 'heart failure with reduced ejection fraction'). The main goal is to find warning signs, called 'congestion markers,' before people leave the hospital. These markers could be things doctors see in an examination, levels in blood tests, or findings from ultrasound scans. By identifying these markers, researchers hope to predict and prevent patients having to return to hospital within three months or, in the worst case, dying. This is a single-centre study, meaning it's happening at one hospital, and everyone taking part has agreed to join.

At a glance

Status

Recruiting

Phase

Sponsor

Central Hospital, Nancy, France

Enrolment target

200

Start

21 Aug 2020

Estimated completion

21 Aug 2028

Acute Heart Failure

What is this study about?

Heart failure is a condition where your heart isn't pumping blood as well as it should. This study is for people who have a specific type called 'heart failure with reduced ejection fraction,' which means the main pumping chamber of your heart isn't squeezing strongly enough. When your heart isn't pumping effectively, fluid can build up in your body, leading to symptoms like swelling in your legs, ankles, or belly, and breathlessness. Doctors call this fluid build-up 'congestion.'

When people are very unwell with heart failure, they often need to go into hospital. Once they start to get better, doctors aim to get them well enough to go home. However, sometimes even after leaving the hospital, people can quickly become unwell again and need to be readmitted. This study wants to understand why this happens.

Researchers are looking for specific warning signs, or 'markers,' that might show doctors which patients are more likely to have problems after leaving the hospital. These markers could be things doctors find during a normal check-up, levels in your blood, or what they see using special ultrasound scans (which are like safe, painless pictures of your insides). By finding these markers, the hope is that doctors can identify patients at higher risk and provide them with extra care or different treatments to help them stay healthier and out of hospital for longer after they go home.

Key takeaways

Aims to find warning signs in hospital to prevent readmission for heart failure.
Uses extra examinations, blood tests, and ultrasound scans.
Specifically for people with 'heart failure with reduced ejection fraction'.
Participation involves extra tests and follow-up phone calls.
Helps doctors understand how to improve care for heart failure patients.

Who may be eligible?

To take part in this study, you must be at least 18 years old and currently in hospital because your heart failure has worsened. You also need to have a specific type of heart failure where your heart isn't pumping blood strongly enough (this is called 'reduced ejection fraction'). The hospital staff should feel you are well enough to be discharged soon.

There are some reasons why you might not be able to join. For example, if you have another serious illness that means you are not expected to live longer than three months, or if you are on kidney dialysis, or have severe kidney problems. You also can't take part if you've had certain lung surgeries or have severe lung conditions that would make it difficult to do the ultrasound scans, or if you are pregnant, breastfeeding, or a new mother.

Finally, you need to be able to understand what the study involves and agree to take part by signing a consent form. This is very important. Also, you must be covered by a social security scheme. Certain legal situations, like being under guardianship or deprived of liberty, would also prevent you from joining.

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 or older?
Are you currently in hospital for worsening heart failure?
Do you have 'heart failure with reduced ejection fraction'?
Are you expected to be discharged from hospital soon?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several assessments while you are still in the hospital and after you go home. While in hospital, you'll have extra clinical examinations focusing on signs of fluid build-up. You'll also have various ultrasound scans of your heart, lungs, belly (around your liver), and neck to look at blood flow. A blood sample will be taken for tests and stored for future research. After you leave the hospital, you'll have a couple of follow-up phone calls. During one of these calls, you'll also be asked to answer questions from a questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ), which asks about how your heart failure symptoms affect your daily life. The study aims to follow you for up to 3 months after you leave the hospital.

Potential risks and benefits

The main benefit of taking part is contributing to medical knowledge that could help improve care for future patients with heart failure. While there aren't direct medical benefits to you from the extra tests, some people find comfort in being actively involved in research. The main risks are minor and relate to the inconvenience of additional tests, like the blood draws, which might cause a little bruising or discomfort, and the time taken for the extra examinations and phone calls. 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 'heart failure with reduced ejection fraction'?

It means your heart's main pumping chamber doesn't squeeze as strongly as it should, making it harder to pump blood around your body.

What does 'congestion' mean?

Congestion in heart failure means there's too much fluid build-up in your body, which can cause swelling and breathlessness.

Will I get new medication in this study?

No, this study is observational, meaning it mostly involves extra tests and information gathering, not new or experimental medications.

What is an ultrasound scan?

An ultrasound uses sound waves to create pictures of inside your body. It's safe, painless, and doesn't use radiation.

How long will I be followed in this study?

You will be followed for up to 3 months after you are discharged from the hospital.

How to find out more

Nicolas GIRERD

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.