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NCT07498868

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

Sponsor: Swansea Bay University Health Board

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

618

Start Date

2026-05

Completion Date

2028-09

Last Updated

2026-03-27

Healthy Volunteers

No

Locations (1)

Swansea Bay Lymphoedema Clinic, Singleton Hospital

Swansea, Swansea, United Kingdom