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

Heart Valve Diseases Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208567
• Other study ID #: 292737
• Status: Recruiting
• Start date: March 14, 2023
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Queen Mary University of London
• Contact: Nabila Laskar, MBBS
• Phone: 02073777000
• Email: nabila.laskar[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Greater or equal to 65 years old

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Diagnostic Test:
• Echocardiogram
Cardiac Ultrasound Scan - using an abbreviated protocol

Locations

Country	Name	City	State
United Kingdom	St Bartholomews Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Queen Mary University of London	Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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