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

March 23, 2023 updated by: Queen Mary University of London

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomews Hospital
        • Contact:
        • Principal Investigator:
          • Guy Lloyd, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are ≥65yrs old who are attending their GP practice for an appointment will be studied. All patients with pre-existing diagnoses of valvular heart disease or Left Ventricular Dysfunction will also be included.

Description

Inclusion Criteria:

- Greater or equal to 65 years old

Exclusion Criteria:

  • Clinical diagnosis of Alzheimer's Disease or Vascular Dementia
  • Palliative Care patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants within a North East London community over the age of 65yrs old with Valvular Heart Disease, as assessed by Cardiac Ultrasound
Time Frame: 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
12 months
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
Time Frame: 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.
12 months
Diagnostic accuracy in identifying heart valve disease or left ventricular systolic dysfunction using abbreviated echocardiography following training protocols.
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

Barts & The London NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292737

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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