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12-Minute test could uncover hidden heart failure in leg swelling patients

NCT ID NCT07498868

Diagnosis Sponsor: Swansea Bay University Health Board Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study will test a rapid finger-prick blood test for heart failure in 618 people with leg swelling (lymphoedema) who have not been diagnosed with heart failure. The test measures a substance called NT-proBNP and gives results in 12 minutes, compared to the usual lab test that takes days. Researchers want to see if this quick test helps find hidden heart failure earlier, reduces unnecessary doctor visits, and saves money for the health system.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NT-proBNP point-of-care test
What this could lead to
If this works, it could lead to a simple, fast screening test for heart failure in people with leg swelling, catching the condition earlier and reducing hospital visits.
What could go wrong
This is an early observational study, not a treatment trial. The test may not be accurate enough in this specific group, and results may not apply to other clinics or countries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 618 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Lymphoedema patients attending Swansea Bay University Health Board Lymphoedema Service

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient of Swansea Bay University Health Board Lymphoedema Service. * Consent to participate in the study. * Bilateral lower limb oedema. * Aged 18-years or older. * Able to provided informed consent to be involved. * No diagnosis of heart failure. * No NT-proBNP test in the previous 12-months OR increase in lymphoedema severity since an NT-proBNP test in the last 12-months. Exclusion Criteria: * All inclusion criteria not met. * Not a lymphoedema patient in Swansea Bay University Health Board Lymphoedema Service. * Unable to consent for themselves. * Women who are pregnant or have given birth in the last 6-months. * Patients with an existing heart failure diagnosis.

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Conditions

The condition(s) this trial relates to.

Edema heart failure lymphedema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Heart failure (for example, fluid overload) Heart failure (HF) Lymphedema Lymphedema, lower limb

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Swansea Bay Lymphoedema Clinic, Singleton Hospital

    Swansea, Swansea, SA2 8QA, United Kingdom

More trials for these conditions

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