RecruitingNAINTERVENTIONAL

Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study

This study, called PEDAL-HF, is investigating the best ways to look after people with heart failure. It involves 1,000 patients in Germany who have recently experienced a sudden worsening of their heart failure and needed hospital care. Some patients will receive care through a special 'heart failure network', while others will have their usual care. Researchers want to see if network care makes a difference by checking levels of a specific heart chemical called NT-proBNP in their blood after six months. All patients will be followed for two years to understand more about how their condition progresses.

At a glance

Status

Recruiting

Phase

Sponsor

University of Leipzig

Enrolment target

1,000

Start

28 Nov 2024

Estimated completion

31 Dec 2028

Heart Failure - NYHA II - IV

What is this study about?

Heart failure is a condition where your heart can't pump enough blood around your body. Sometimes, people with heart failure have episodes where their symptoms suddenly get much worse, and they need to go to hospital. The PEDAL-HF study wants to understand if a specific approach to care, called a 'heart failure network', can help people who have recently been discharged from hospital after one of these episodes.

A heart failure network is a way of organising care that aims to make sure patients get all the different types of support they need from various specialists, working closely together. The study will compare this network care to the usual care patients would receive.

The main aim is to see if there's a difference in a blood test marker called NT-proBNP after six months. This marker helps doctors understand how well the heart is working. By following patients for two years, the study hopes to learn more about how different types of care affect the long-term health of people with heart failure.

Key takeaways

This study is looking at care for people recently hospitalised for worsening heart failure.
It compares a 'heart failure network' care approach with usual care.
Researchers will check a blood marker (NT-proBNP) to see if the care makes a difference.
The study aims to improve understanding of long-term heart failure management.
Participation lasts for two years and involves health monitoring.

Who may be eligible?

To be able to join this study, you would need to be an adult (18 years or older) and have recently been admitted to one of the participating hospitals in Germany because your heart failure symptoms suddenly got worse. Doctors would also need to have seen clear signs that your heart has some structural problems, according to standard medical guidelines.

There are also some reasons why you wouldn't be able to join. You can't participate if you are under 18 or if you are pregnant. Also, if there's any reason that would make it difficult for you to understand what's involved and give your proper agreement to take part, you wouldn't be able to join. Finally, if you are living in an institution because of a court order or official decision, you also wouldn't be able 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.

I am 18 years old or older.
I have recently been in hospital because my heart failure suddenly got worse.
My doctors have identified clear structural problems with my heart.
I am not pregnant.
I am able to understand information and give my full agreement to join the study.

Answer every question to see your result.

What does participation involve?

If you join the PEDAL-HF study, you'll be followed for two years. Initially, some patients will be randomly chosen to either receive care through a heart failure network or continue with their usual care. The main thing that will be checked is a blood test for NT-proBNP at the beginning and again after six months. Throughout the two years, researchers will keep track of your health and how your heart failure progresses, likely through regular check-ups and reviewing your medical records.

Potential risks and benefits

Taking part in this study may help researchers learn more about the best ways to care for people with heart failure, which could benefit others in the future. For you personally, there's no guarantee of direct benefit from the study interventions beyond the care you would already receive. The study involves regular monitoring and blood tests, which may cause minor discomfort. You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

University Hospital Leipzig
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is 'heart failure network care'?

It's a way of organising your medical care where different specialists work together closely to make sure you get all the support you need for your heart failure.

What does 'NYHA II - IV' mean?

This is a way doctors classify how much your heart failure symptoms affect your daily life. II means mild symptoms, and IV means severe symptoms, even at rest.

What is NT-proBNP?

It's a chemical in your blood that doctors can measure to get an idea of how much strain your heart is under. Higher levels can suggest worsening heart failure.

Will I definitely get network care if I join?

Not necessarily. For part of the study, patients are randomly chosen to either receive network care or continue with their usual care, like a lottery.

How long will I be involved in the study?

All patients in the study will be followed for a period of two years.

How to find out more

Rolf Wachter, MD

rolf.wachter@medizin.uni-leipzig.de +49-341-97-12650 Official trial record

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