NCT07498868

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
618

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Sep 2028

First Submitted

Initial submission to the registry

March 6, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 6, 2026

Last Update Submit

March 23, 2026

Conditions

Lymphedema, Lower LimbLymphedemaHeart FailureHeart Failure (for Example, Fluid Overload)Heart Failure (HF)

Keywords

lymphoedemaheart failureundetected heart failureundiagnosed heart failurebilateral lower limb oedemabilateral leg oedemapoint of care testingscreeningNT-proBNP

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 1.

Secondary Outcomes (13)

  • Point of care NT-proBNP test result

    Day 1.

  • Definitive diagnosis

    At the time of the cardiology appointment, up to 14-weeks.

  • Time to definitive diagnosis

    At the time of the cardiology appointment, up to 14 weeks.

  • Change in number of healthcare system interactions.

    Day 1.

  • Change in travel time.

    Day 1.

  • +8 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lymphoedema patients attending Swansea Bay University Health Board Lymphoedema Service

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Patients with an existing heart failure diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea Bay Lymphoedema Clinic, Singleton Hospital

Swansea, Swansea, SA2 8QA, United Kingdom

Location

Related Publications (15)

  • J. L. Januzzi et al., 'NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: An international pooled analysis of 1256 patients: The international collaborative of NT-proBNP study', Eur Heart J, vol. 27, no. 3, pp. 330-337, Feb. 2006, doi: 10.1093/eurheartj/ehi631

    BACKGROUND

  • P. Shah, L. Mason, K. Thomas, and D. Rucarean, 'Heart Failure Service in Swansea Bay', in Welsh Heart Failure Society, Swansea, Sep. 2024

    BACKGROUND

  • National Institute for Health and Care Excellence, 'Heart failure - chronic'

    BACKGROUND

  • A. Bayes-Genis and G. Rosano, 'Unlocking the potential of natriuretic peptide testing in primary care: A roadmap for early heart failure diagnosis', Aug. 01, 2023, John Wiley and Sons Ltd. doi: 10.1002/ejhf.2950

    BACKGROUND

  • P. Bachtiger et al., 'Survival and health economic outcomes in heart failure diagnosed at hospital admission versus community settings: a propensity-matched analysis', BMJ Health Care Inform, vol. 30, no. 1, Mar. 2023, doi: 10.1136/bmjhci-2022-100718

    BACKGROUND

  • B. Hayhoe, D. Kim, P. P. Aylin, F. Azeem Majeed, M. R. Cowie, and A. Bottle, 'Adherence to guidelines in management of symptoms suggestive of heart failure in primary care', Heart, vol. 105, no. 9, pp. 678-685, May 2019, doi: 10.1136/heartjnl-2018-313971

    BACKGROUND

  • A. Bottle, D. Kim, P. Aylin, M. R. Cowie, A. Majeed, and B. Hayhoe, 'Routes to diagnosis of heart failure: Observational study using linked data in England', Heart, vol. 104, no. 7, pp. 600-605, Apr. 2018, doi: 10.1136/heartjnl-2017-312183

    BACKGROUND

  • G. Cooper-Stanton, 'Long-term conditions Compression therapy and heart failure: a scoping review of the existing evidence', 2022

    BACKGROUND

  • G. Cooper and D. Brown, 'Integrating compression therapy into heart failure and lymphoedema management', Br J Community Nurs, vol. 29, Oct. 2024, doi: 10.12968/bjcn.2024.0086

    BACKGROUND

  • M. Frigerio, F. Oliva, F. M. Turazza, and R. O. Bonow, 'Prevention and management of chronic heart failure in management of asymptomatic patients', in American Journal of Cardiology, Elsevier Inc., May 2003, pp. 4-9. doi: 10.1016/S0002-9149(02)03335-0

    BACKGROUND

  • C. Sung, S. Wang, J. Hsu, R. Yu, and A. K. Wong, 'Current understanding of pathological mechanisms of lymphedema', Adv Wound Care (New Rochelle), vol. 11, no. 7, pp. 361-373, Jul. 2022, doi:10.1089/wound.2021.0041

    BACKGROUND

  • A. L. Clark and J. G. F. Cleland, 'Causes and treatment of oedema in patients with heart failure', Mar. 2013. doi: 10.1038/nrcardio.2012.191

    BACKGROUND

  • T. A. McDonagh et al., '2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure', Sep. 21, 2021, Oxford University Press. doi: 10.1093/eurheartj/ehab368

    BACKGROUND

  • N. Conrad et al., 'Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals', The Lancet, vol. 391, no. 10120, pp. 572-580, Feb. 2018, doi: 10.1016/S0140-6736(17)32520-5

    BACKGROUND

  • Z. Cao, Y. Jia, and B. Zhu, 'BNP and NT-proBNP as diagnostic biomarkers for cardiac dysfunction in both clinical and forensic medicine', Apr. 02, 2019, MDPI AG. doi: 10.3390/ijms20081820

    BACKGROUND

MeSH Terms

Conditions

LymphedemaHeart FailureEdema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesHeart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Melanie J Thomas, DProf

    Lymphoedema Wales Clinical Network, Swansea Bay University Health Board

    STUDY DIRECTOR

  • Daniel T Rothwell, PhD

    Lymphoedema Wales Clinical Network, Swansea Bay University Health Board

    PRINCIPAL INVESTIGATOR

Central Study Contacts

National Lymphoedema Team

CONTACT

+4401639862767LWCN.Research@wales.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 27, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

All researchers that will be involved in reviewing and analysing the data collected are included in the Research Team as part of the application for ethical approval submitted to Health and Care Research Wales (HCRW) and the Health Research Authority (HRA).

Locations

GB(1)