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Biomarkers in Patients With Suspected HFpEF

This study aims to improve how doctors diagnose a specific type of heart failure called HFpEF, particularly in people who are overweight or obese. Current blood tests, like NT-proBNP, don't always work well in these groups, sometimes missing heart failure or giving unclear results. Researchers will investigate if different levels for the NT-proBNP test could be more accurate, and they will look for entirely new markers in blood and urine that might help identify heart failure sooner. The goal is to develop better tools for earlier diagnosis, which can help patients get the right care more quickly.

At a glance

Status
Recruiting
Sponsor
NHS Greater Glasgow and Clyde
Enrolment target
1,028
Start
02 Feb 2023
Estimated completion
29 Sep 2026

What is this study about?

Imagine your heart is like a pump. Heart failure means your heart isn't pumping blood as well as it should. There's a type of heart failure called HFpEF where the heart muscle works fine, but it's too stiff to fill properly with blood. This can make you feel tired or breathless, but it can be really tricky for doctors to diagnose.

Doctors often use a blood test called NT-proBNP to help check for heart failure. While this test is quite good for many people, it sometimes doesn't work as well, especially in people who are overweight or obese. In fact, some people with HFpEF and obesity might have perfectly normal NT-proBNP levels, even though they have heart failure. This can lead to delays in getting a diagnosis and treatment, which isn't good for your health.

This study wants to find better ways to spot HFpEF. Researchers will look at people who are suspected of having heart failure and explore if adjusting the 'normal' levels for the NT-proBNP test could make it more accurate, especially for those with obesity. They will also search for completely new markers in blood and urine that could help doctors identify heart failure earlier. The aim is to make diagnosis more reliable, so people can get the care they need sooner.

Key takeaways

  • This study aims to improve the diagnosis of a type of heart failure called HFpEF.
  • It focuses on people who are overweight or obese, where current tests might not be accurate.
  • Researchers will look for new markers in blood and urine to help identify heart failure earlier.
  • Participation involves an initial visit with health checks and blood/urine tests.
  • Your health records will be followed for about 10 years, but there are no further study visits.
  • This research hopes to lead to better diagnosis and earlier treatment for future patients.

Who may be eligible?

This study is looking for adults aged 18 or over who have recently had a blood test for NT-proBNP because their doctor suspected they might have heart failure, and they haven't been diagnosed with heart failure before.

To join, you'll need to be able to understand the study and agree to take part. Also, you'll need to be able to come to the study centre for check-ups and assessments.

You won't be able to join if you've already been diagnosed with heart failure, if you're currently having a sudden, severe episode of heart failure, or if you can't come to the study centre due to travel difficulties or other reasons.

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.

  1. Are you 18 years old or older?
  2. Has your doctor recently ordered an NT-proBNP blood test because they suspect you might have heart failure?
  3. Have you *not* already been diagnosed with heart failure?
  4. Are you able to travel to a study clinic for assessments?
  5. Are you able to understand the study information and give your permission?
  6. Are you *not* currently having a sudden, severe heart failure episode?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be asked to give your written permission. You'll have an initial visit where a doctor will talk to you about your medical history and do a physical check-up. You'll also complete some questionnaires about how you're feeling. Other tests will include an ECG (a heart tracing), an echocardiogram (a scan of your heart), and blood and urine samples will be collected for analysis. No medication will be given as part of this study.

The heart failure experts will then use all this information to make a diagnosis of heart failure, if appropriate, and see how well this matches the levels of different markers found in your blood and urine samples.

After these initial assessments, you won't need to come back for regular study visits. Instead, the researchers will keep track of your health over approximately 10 years by linking up with your hospital records. This means they'll passively monitor any future hospital visits or health events.

Potential risks and benefits

Taking part in this study may not directly benefit your health immediately, but the information found could lead to improved diagnosis of heart failure for future patients. The main risks involve the procedures you'd typically have for a check-up, such as blood tests, which might cause minor bruising or discomfort. You also have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (3)

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· Recruiting
  • New Victoria Hospital
    Verified postcode
    Glasgow, United Kingdom· Recruiting
  • Queen Elizabeth University Hospital
    Verified postcode
    Glasgow, United Kingdom· Recruiting

Common questions

What is HFpEF?

HFpEF is a type of heart failure where your heart muscle is stiff and can't fill with enough blood, even though it pumps well. This can make you feel breathless and tired.

What is NT-proBNP?

NT-proBNP is a substance released by your heart when it's under stress. Doctors measure its level in a blood test to help diagnose heart failure.

Why doesn't the NT-proBNP test always work well?

For some people, especially those with obesity, NT-proBNP levels might appear normal even if they have heart failure. This can make diagnosis difficult.

What are 'biomarkers'?

Biomarkers are measurable substances in blood or urine that can indicate a particular disease or condition. This study is looking for new ones that could help detect heart failure.

Will I have to take any new medicines?

No, this study does not involve giving any new medications. It's about finding better ways to diagnose heart failure.

How to find out more

Ross Campbell, MBChB

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

Interested in taking part?

Register your interest

Share your details and the research team for "Biomarkers in Patients With Suspected HFpEF…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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