About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient of Swansea Bay University Health Board Lymphoedema Service.
Consent to participate in the study.
Bilateral lower limb oedema.
Aged 18-years or older.
Disqualifiers
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.
Trial population
Lymphoedema patients attending Swansea Bay University Health Board Lymphoedema Service
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of participants that need a heart failure investigation.
The number of bilateral lower limb lymphoedema patients with a point of care NT-proBNP level greater than 400 ng/L who need to be investigated for possible undetected heart failure.
Secondary outcomes
Point of care NT-proBNP test result
The NT-proBNP test result when performed at the point of care.
Definitive diagnosis
The outcome of the heart failure/clinical research appointment.
Time to definitive diagnosis
The time from the point of care test to receiving the diagnosis at the end of the clinical research appointment, for each patient.
Change in number of healthcare system interactions.
The change in the number of healthcare system interactions that providing the test at the point of care allows, compared to using laboratory testing.
Sponsors and contacts
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Swansea Bay University Health Board
Lead sponsor
NHS Wales Performance and Improvement
Collaborator
This trial is not recruiting at the moment. You can still explore other options: