Safety & Utility of an App to Guide Timing of AVR in Asymptomatic sAS
Research type
Research Study
Full title
A Study to Assess the Safety, Effectiveness and Prognostic Utility of a Smart Device App to Guide the Timing of Valve Intervention in Patients with Asymptomatic Severe Aortic Stenosis (APRAISE-AS)
IRAS ID
272195
Contact name
Nazish Khan
Contact email
Sponsor organisation
The University of Birmingham
ISRCTN Number
ISRCTN19413194
Duration of Study in the UK
2 years, 2 months, 0 days
Research summary
Aim: find out whether an app-based remote monitoring system in addition to standard care improve the management of people with asymptomatic severe aortic stenosis.
Background: The commonest presentation of heart valve disease is a narrowing of the aortic valve known as aortic stenosis (AS). The process which causes this narrowing develops over years, which is why it affects mainly older adults. There aren’t any medications that prevent AS. In people with severe AS who develop symptoms (tiredness, breathlessness, collapse), the only treatment is aortic valve replacement. In those with severe AS, but who are asymptomatic, currently, 6-monthly hospital-based clinic visits are recommended and once symptoms appear, the aortic valve is replaced. Here, we rely on people to self-report development of symptoms. However, symptoms are often confused with “getting older” and may not be flagged, leading to delays in valve replacement and possibly poor outcomes.
Current Study: As part of a pilot trial, adults with asymptomatic severe AS will be randomised to either standard care (6 monthly outpatient clinic appointments) or to standard care + app-based reporting of symptoms, quality of life and exercise capacity. This information will be collected at regular intervals and reviewed by the clinical team over a 12-month period and used to help make treatment decisions. We want to find out whether remote patient monitoring using a smart device app in addition to standard of care, will allow us to pick up potential deterioration sooner. Earlier intervention may lead to improved survival, well-being and prevent unwanted hospital admissions.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
22/WM/0214
Date of REC Opinion
5 Dec 2022
REC opinion
Further Information Favourable Opinion