Medico-economic Evaluation of Therapeutic Adaptation Guided by the Soluble Suppression of Tumorigenicity 2 (sST-2) Biomarker in the Management of Patients With Acute Heart Failure
This study, called ICAME, aims to find out if using a blood test called sST2 to guide treatment can improve care for people with heart failure. Heart failure can lead to frequent hospital visits and can impact daily life. Researchers hope that by regularly checking sST2 levels, doctors can make better treatment decisions, which might reduce the number of times patients need to be readmitted to the hospital and ultimately improve their quality of life. The study involves comparing patients who receive usual care with those whose treatment is adjusted based on their sST2 levels, tracking them for two years.
At a glance
What is this study about?
Heart failure is a serious condition where your heart doesn't pump blood as well as it should. This can make everyday activities difficult and often leads to hospital stays. Doctors are always looking for better ways to manage heart failure to help people live longer, healthier lives and avoid repeated hospital visits.
This study is looking at a new approach to managing heart failure. It focuses on a special marker in your blood called sST2. This marker can give doctors clues about how your heart is doing. The idea is that if doctors know your sST2 levels, they might be able to adjust your treatment more effectively, potentially before problems get too big.
Researchers want to see if using this sST2 marker to guide treatment will lead to fewer hospital readmissions for heart failure and improve how people feel and their overall quality of life. Half of the participants will receive care where doctors are aware of their sST2 levels and use them to help make treatment decisions, while the other half will receive standard care where doctors don't know the sST2 levels. This helps researchers compare the two approaches fairly.
Key takeaways
- The study aims to improve heart failure treatment.
- It uses a blood test called sST2 to guide treatment decisions.
- The goal is to reduce hospital stays and improve quality of life.
- It involves comparing this new approach with standard care.
- Participation lasts for two years with regular check-ups.
Who may be eligible?
To be able to join this study, you must be 18 years old or older and have recently been in the hospital because of heart failure. Your doctor will confirm this with a blood test result (NTproBNP of 450 pg/ml or more, or BNP of 400 pg/ml or more).
There are several reasons why someone might not be able to join. These include if you are currently waiting for a heart transplant or scheduled for heart valve surgery. You also can't take part if you are pregnant, are already in another research study, or if your heart condition is unstable right now. You would also need to be able to speak French fluently and be able to understand and agree to take part.
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 recently been in hospital for heart failure (with specific blood test results)?
- Are you able to speak French fluently?
- Are you not waiting for a heart transplant or scheduled for valve surgery soon?
- Are you not currently pregnant or participating in another research study?
What does participation involve?
If you decide to join this study, you would be involved for a total of two years. You would either receive standard care, or your doctors might adjust your treatment based on your sST2 blood test results. You would have check-up appointments at 6, 12, 18, and 24 months, where the research team would assess your health and wellbeing. These check-ups are part of the study's plan to see how your health changes over time.
Potential risks and benefits
Locations (12)
- Lapeyronie HospitalVerified postcodeMontpellier, France· Active not recruiting
- CHU AngersVerified postcodeAngers, France· Recruiting
- CHU BesançonVerified postcodeBesançon, France· Recruiting
- CH BéziersVerified postcodeBéziers, France· Recruiting
- CHU CaenVerified postcodeCaen, France· Recruiting
- CHU GrenobleVerified postcodeGrenoble, France· Recruiting
- Arnaud de Villeneuve HospitalVerified postcodeMontpellier, France· Recruiting
- CHU NimesVerified postcodeNîmes, France· Recruiting
- APHP PompidouVerified postcodeParis, France· Not yet recruiting
- CHU RennesVerified postcodeRennes, France· Not yet recruiting
- CHU ToulouseVerified postcodeToulouse, France· Recruiting
- CHU VannesVerified postcodeVannes, France· Recruiting
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood as effectively as it should, leading to symptoms like tiredness or breathlessness.
What is sST2?
sST2 is a marker found in your blood that can give doctors clues about your heart's health, especially if you have heart failure.
Will I know if I'm getting the new treatment?
No, you won't know if your treatment is being guided by the sST2 test or if you're in the standard care group. This helps keep the study fair.
How long will the study last for me?
If you join, you will be followed for a total of two years.
Do I have to speak French to join?
Yes, to participate in this specific study, you need to be able to speak French fluently as the study is being conducted in French-speaking centres.
How to find out more
Jean-Paul CRISTOL, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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