Active not recruitingNAINTERVENTIONAL

Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure

This study aims to discover a better way to find heart failure that hasn't been diagnosed yet in people with diabetes who face a higher risk. Heart failure means your heart isn't pumping blood as well as it should, and it can become serious if not found early. We're comparing two groups: one gets usual care for their diabetes, and the other gets a special blood test (called NT-proBNP) to look for signs of heart trouble. If this test shows high levels, more checks will be done. The goal is to see if this special screening helps catch heart failure earlier, potentially improving health outcomes for people living with diabetes.

At a glance

Status

Active not recruiting

Phase

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

706

Start

22 Dec 2022

Estimated completion

01 Dec 2032

Heart Failure Diabetes Mellitus Type 1 Diabetes Type 2 Diabetes Cardiovascular Diseases

What is this study about?

This research study, called TARGETED-HF, is all about finding better ways to spot heart failure early in people who have diabetes and also have other risk factors. Heart failure can be serious, but if it's found sooner, doctors can often start treatments that help manage it and improve your quality of life. Many people with diabetes might have early signs of heart failure without even knowing it.

The study involves patients from two NHS health boards in Scotland. Half of the participants will receive their usual diabetes care, just as they would normally. The other half will have a special blood test, called NT-proBNP, which can indicate stress on the heart. If this test shows a higher level, it will prompt further investigations to check for heart failure.

The main goal is to see if actively looking for heart failure with this blood test helps to diagnose it earlier compared to just waiting for symptoms to appear. This could lead to people getting the right care sooner, preventing the condition from getting worse, and ultimately improving their health and wellbeing. We'll also collect information about participants' overall health and quality of life.

Key takeaways

Targets early detection of hidden heart failure in people with diabetes.
Compares standard care with a new blood test (NT-proBNP) for screening.
Aims to improve care by finding heart problems sooner.
Involves patients from NHS Greater Glasgow and Clyde and NHS Lanarkshire.
Participation involves either routine care or extra tests and questionnaires.

Who may be eligible?

To join this study, you need to be 40 years old or older and have either Type 1 or Type 2 diabetes. You also need to have at least one other risk factor for heart failure. These risk factors could include having had a previous heart attack or certain heart procedures, persistent irregular heartbeat (atrial fibrillation), a past stroke, certain conditions affecting blood flow to your legs, or ongoing kidney problems. Taking certain water pills (loop diuretics) regularly for over a month, or having a lung condition like COPD, also counts as a risk factor.

There are also some reasons why you wouldn't be able to join. For example, if you've already been diagnosed with heart failure, or if recent heart tests have shown that you definitely don't have heart failure. You also can't take part if you're undergoing regular kidney dialysis, or if for any other reason the study doctors feel it wouldn't be safe or appropriate for you.

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 40 years old or older?
Do you have Type 1 or Type 2 diabetes?
Do you have a history of heart attack, stroke, or severe kidney problems?
Are you taking water pills (diuretics) regularly for more than a month?
Have you been told you have COPD or a similar lung condition?
Have you been previously diagnosed with heart failure? (If yes, you can't join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups, like flipping a coin. One group will continue with their usual diabetes care, and we'll keep an eye on your health remotely. The other group will have some extra tests. This involves a blood test to check a marker called NT-proBNP, along with other routine blood tests. You'll also have a heart tracing (ECG) and some basic body measurements like your blood pressure and weight.

Both groups will be asked to complete some questionnaires about your quality of life, usually on a computer or tablet, but paper versions are available if needed. For the group getting extra tests, some blood and urine samples will also be stored for future research, with your permission. The study will monitor your health over time to see if any heart failure events occur. The total duration of your participation will depend on the study design, but generally involves monitoring your health and completing questionnaires over several months or longer.

Potential risks and benefits

Taking part in this study could potentially lead to earlier detection of heart failure if you have it unknowingly, which might mean you can start treatments sooner and improve your long-term health. However, there's always a small risk with any blood test, like temporary bruising or discomfort. You also might find the questionnaires or clinic visits take up some of your time. It’s important to remember that your participation is completely voluntary, and you can choose to withdraw from the study at any time without affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Glasgow Royal Infirmary
Verified postcode
Glasgow, United Kingdom
Queen Elizabeth University Hospital
Verified postcode
Glasgow, United Kingdom

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood around your body as efficiently as it should. It can lead to symptoms like breathlessness and tiredness.

What is NT-proBNP?

NT-proBNP is a substance released into your blood when your heart muscle is under stress. Higher levels can be a sign of heart problems.

Will I get paid to participate?

The study information doesn't mention payment for participation. It's usually voluntary to help advance medical understanding.

What happens if I'm in the 'routine care' group?

You'll continue with your standard diabetes care. The study will monitor your health remotely and you'll be asked to complete quality of life questionnaires.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.