RecruitingNAINTERVENTIONAL

Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure

This study is for people aged 65 and over who are having common, non-heart surgery and might be at risk of heart problems. Researchers want to see if a specially organised care plan, involving different medical teams working together, can help reduce complications after an operation. Many people in the UK have heart failure, and undergoing surgery can sometimes lead to extra risks. This study tests whether a more joined-up approach to care, starting before surgery, can make these operations safer for vulnerable patients. Patients will be checked for a specific heart marker, and if it's high, they might be invited to take part.

At a glance

Status

Recruiting

Phase

Sponsor

University of Giessen

Enrolment target

1,057

Start

01 Sep 2024

Estimated completion

01 Mar 2027

Heart Failure

What is this study about?

Heart failure is a common condition where your heart doesn't pump blood around your body as well as it should. It affects many people, especially as they get older. When someone with heart failure needs to have surgery for something else – not on their heart itself – there can be a higher chance of complications, or even serious problems, after the operation. This study is being done because healthcare professionals want to find better ways to look after these patients. They've noticed that even though guidelines say these patients should have careful checks before surgery, it doesn't always happen in a structured way.

This research aims to test if bringing different medical teams together (like heart doctors, anaesthetists, and surgeons) to plan and deliver care can improve safety. They are particularly focusing on older patients, aged 65 and above, who are having non-heart surgery. Even if someone hasn't officially been diagnosed with heart failure, they might still be included if a specific blood test shows they could be at higher risk.

The main idea is to see if a more coordinated and thorough approach, both before and after surgery, can help reduce problems for these patients. It's about making sure that everyone involved in their care is working together from the start to give them the best possible outcome.

Key takeaways

This study is for people aged 65 or older having non-heart surgery.
It aims to improve surgical safety for patients at risk of heart problems.
Researchers are testing a team-based, coordinated care plan.
You would be included if a specific blood test shows high risk.
Participation involves either standard care or the special care plan.
The goal is to reduce complications after surgery.

Who may be eligible?

To join this study, you would generally need to be 65 years old or older. You'd also be preparing for a common, non-heart-related operation that carries a medium to high risk, carried out under a general anaesthetic (where you're fully asleep) or a mix of general and regional anaesthetic.

During your routine health checks before surgery, your doctor would do a blood test. If a specific marker related to heart failure (called NT-proBNP) is found to be above a certain level, you might then be invited to take part in the study. Your overall health and fitness for surgery, as assessed by a doctor (often called an ASA grade of II or higher), would also be considered.

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 65 years old or older?
Are you scheduled for a non-heart surgery that requires general anaesthesia?
Is your doctor assessing you as having a medium to high risk operation?
Has your doctor done a blood test before surgery that showed a certain heart marker (NT-proBNP) is elevated?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be placed into one of two groups by chance, like flipping a coin. One group will receive the usual care given before and after surgery. The other group will receive the special care plan being tested, which involves more detailed assessments and a team approach to your care. The study will last for your hospital stay and then for a period after you go home. The total duration of your involvement isn't specified, but it will cover your surgical journey and recovery. You won't be asked to take any new medications specifically for the study. Researchers will closely monitor your health and recovery, collecting information from your medical records to see how you're doing.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from being in this study, but your participation could help doctors learn more about improving care for future patients. If you're in the group receiving the special care plan, you might gain from the extra attention and coordinated approach. As with any medical procedure, there are always risks associated with surgery itself, and this study aims to understand how to reduce complications. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Justus Liebig University Giessen, University Hospital Giessen and Marburg
Verified postcode
Giessen, Germany· Recruiting

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as effectively as it should. It can lead to tiredness and shortness of breath.

Why focus on older patients?

Older patients are more likely to have or be at risk of heart failure, which can increase risks during non-heart surgery.

What kind of surgery is this for?

It's for common surgeries that are not on the heart itself, like hip replacements or abdominal operations, under general anaesthesia.

Will I take new medication if I join?

No, this study doesn't involve giving you new medications. It's about how your existing care is organised and planned.

What is 'interdisciplinary care'?

It means different healthcare professionals, like heart doctors, anaesthetists, and surgeons, work closely together to plan and deliver your care.

How to find out more

Götz Schmidt, MD

goetz.f.schmidt@chiru.med.uni-giessen.de +4964198544401 Official trial record

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