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

NCT07498868 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 618

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Lymphedema, Lower Limb
  • Lymphedema
  • Heart Failure
  • Heart Failure (for Example, Fluid Overload)
  • Heart Failure (HF)

Sponsors & Collaborators

  • NHS Wales Performance and Improvement

    collaborator UNKNOWN

  • Swansea Bay University Health Board

    lead OTHER

Principal Investigators

  • Melanie J Thomas, DProf · Lymphoedema Wales Clinical Network, Swansea Bay University Health Board

  • Daniel T Rothwell, PhD · Lymphoedema Wales Clinical Network, Swansea Bay University Health Board

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-10-31
Completion
2028-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498868 on ClinicalTrials.gov