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

Sponsor
Swansea Bay University Health Board
Study ID
NCT07498868
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Mar 27, 2026
Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
618 participants (estimated)

Arms

  • Arm: Bilateral lower limb lymphoedema patients
    People with bilateral lower limb lymphoedema who do not have a prior diagnosis of heart failure and have not been investigated for heart failure in the last 12-months, unless their oedema has increased in severity.

Primary Outcome Measure

Number of participants that need a heart failure investigation. [ Time Frame: Day 1. ]

Central Contacts

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