Detecting the Undetected: Heart Failure Screening at the Lymphoedema Point of Care

Starting soon

Conditions studied: Lymphedema, Lower Limb, Lymphedema, Heart Failure, Heart Failure (for Example, Fluid Overload), Heart Failure (HF)

In brief

Heart failure affects more people than the four most common cancers combined. When identified early, management is more straightforward, preventing complications, hospitalisations, and fatalities. Breathlessness and fatigue are cardinal symptoms of heart failure that can present in a number of conditions. As a result, leg swelling, the third cardinal symptom, is the first noted in many people. The presence of leg swelling leads to patients being seen in lymphoedema clinics before the need for cardiology investigation has been identified. Lymphoedema is the presence of chronic oedema as a result of congenital abnormalities, inflammation, infection, trauma, or cancer and its treatments. The vast majority of lymphoedema patients have swelling in their legs. A recent study has shown that 9.4% lymphoedema patients need to be investigated for heart failure. At present, the need for investigation is identified by performing a laboratory blood test, which takes time to arrange and complete. An alternate point of care test can provide a result in 12-minutes at the lymphoedema appointment, and enable appropriate action to be taken. This can reduce the demands on primary care and shorten the chain of events to a specialist assessment, as well as reducing inappropriate referrals. This research, funded by NHS Wales Performance and Improvement, will perform a point of care test to screen for possible heart failure in lymphoedema clinics and establish the clinical utility by exploring the experiences of patients and staff involved and determining the health economic benefits. A supplementary aim is to compare the point of care test to the currently used laboratory test in a subsample to promote confidence in the test and support efforts to spread and scale across all health boards in Wales on completion.

Key facts

Study ID

NCT07498868

Run by

Swansea Bay University Health Board

People needed

618

Starts

2026-05-01

Expected to finish

2028-09-01

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Swansea Bay Lymphoedema Clinic, Singleton Hospital — Swansea, Swansea, United Kingdom

Full record on ClinicalTrials.gov

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