NCT05208567

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress91%
Mar 2023Sep 2026

First Submitted

Initial submission to the registry

January 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2026

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

January 21, 2022

Last Update Submit

February 19, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of participants within a North East London community over the age of 65yrs old with Valvular Heart Disease, as assessed by Cardiac Ultrasound

    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

    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.

    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

Interventions

EchocardiogramDIAGNOSTIC_TEST

Cardiac Ultrasound Scan - using an abbreviated protocol

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- Greater or equal to 65 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Bartholomews Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Valve DiseasesVentricular Dysfunction, Left

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVentricular Dysfunction

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Nabila Laskar, MBBS

CONTACT

Guy Lloyd, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

January 26, 2022

Study Start

March 14, 2023

Primary Completion (Estimated)

August 2, 2026

Study Completion (Estimated)

September 2, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations