NCT07498868Not yet recruiting
Detecting the Undetected: Heart Failure Screening at the Lymphoedema Point of Care
Detecting the Undetected: an Observational Cohort Study Evaluating the Health Economics, Clinical Utility, and Patient and Staff Experiences of Innovative Peptide Testing to Screen for Heart Failure in Lymphoedema Clinics
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 618 (estimated)
- First submitted
- 6 Mar 2026
- Start date
- May 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- Swansea Bay University Health Board
- Diseases
- Heart failure
- NCT number
- NCT07498868
What you commit to
- Study type: Observational
- Planned participants: 618
- From May 2026 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with an existing heart failure diagnosis.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Swansea Bay Lymphoedema Clinic, Singleton Hospital Coordinator of this site? Confirm its status | Swansea | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.