LOVE: London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound

Sponsor
Queen Mary University of London (Other)
Overall Status
Recruiting
CT.gov ID
NCT05208567
Collaborator
Barts & The London NHS Trust (Other)
500
1
24
20.8

Study Details

Study Description

Brief Summary

Heart Valve Disease and Heart failure contribute to 25% of hospital emergency admissions while heart failure alone has become one of the most common causes for hospitalisation in people over the age of 65. The burden of disease is likely to be high in a multi-ethnic community but there is a paucity of data. Management of heart valve disease requires appropriate surveillance and timely surgery. Similarly heart failure management requires treatment with medications aimed at slowing prevention of symptoms and preventing premature death. The NHS long term plan priorities early detection and treatment of valve disease and heart failure in order to reduce the burden on emergency services and improve the health of the population.

Diagnosis is made using cardiac ultrasound, however staff with the required skills-set are critically limited in the community.

The investigators will train non-expert staff within primary care to perform abbreviated cardiac ultrasound to detect heart valve disease or heart failure. This will be opportunistic scanning to reduce healthcare footfall.

All scans will be reviewed by an expert and the investigators will use the anonymised data to develop machine learning tools to begin working with academic partners to develop tools that can improve the reliability of diagnosis from ultrasound.

The investigators hope to identify the proportion with the above conditions in a multi-ethnic community and assess the feasibility of developing a program where staff can be trained for community detection, streamlined referrals can be created bridging the gap between primary and secondary care, reducing hospital emergency admissions, while ensuring patients are managed optimally.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Echocardiogram

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Number of participants within a North East London community over the age of 65yrs old with Valvular Heart Disease, as assessed by Cardiac Ultrasound [12 months]

    Participants will be recruited while attending their routine health check at their GP practice and consented for a cardiac ultrasound to identify Valvular Heart Disease

  2. Number of participants within a North East London community over the age of 65yrs old with Left Ventricular Systolic Dysfunction as assessed by Cardiac Ultrasound [12 months]

    Participants will be recruited while attending their routine health check at their GP practice and consented for a cardiac ultrasound to identify Left Ventricular Systolic Dysfunction.

  3. Diagnostic accuracy in identifying heart valve disease or left ventricular systolic dysfunction using abbreviated echocardiography following training protocols. [12 months]

    Trainees will be taught how to perform and interpret focussed cardiac ultrasound scans, their interpretations and performance will be measured against an expert's and compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Greater or equal to 65 years old
Exclusion Criteria:
  • Clinical diagnosis of Alzheimer's Disease or Vascular Dementia

  • Palliative Care patients.

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Bartholomews Hospital London United Kingdom EC1A 7BE

Sponsors and Collaborators

  • Queen Mary University of London
  • Barts & The London NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT05208567
Other Study ID Numbers:
  • 292737
First Posted:
Jan 26, 2022
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2022