A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis

Status: Recruiting
Location: See all (110) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Aortic stenosis (AS) affects approximately 5% of individuals \>65 years old, with \ 3% of people \>75 years having moderate to severe disease. The prevalence of AS is rising rapidly due to an ageing population and is projected to double in the next two decades. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms because the heart compensates for the AS. Ultimately, compensatory mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients with severe AS remain untreated, they have a dire prognosis. In this situation the only effective treatment is AVR, either surgically or using TAVI. Conversely, conventional teaching and clinical practice in cardiology has been that, in the absence of symptoms, the prognosis is usually excellent and, except in a few very specific circumstances, conservative management and regular review (expectant management) is recommended. This advice is reflected in current international guidelines but is based largely on historical precedent. There has never been a randomised controlled trial to address the relative benefits of early AVR versus expectant management in patients with severe asymptomatic AS. The relative benefits of a strategy of early AVR/TAVI versus expectant management in patients with asymptomatic severe AS are unclear. There is clinical equipoise but it remains one of the few areas of cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The EASY-AS study will provide crucial data on the relative merits of these differing approaches to management, in terms of important patient orientated outcomes, conventional cardiovascular end-points and cost effectiveness.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

• Patient has severe asymptomatic AS, in line with current international guidelines, defined as either:

‣ Peak velocity ≥4m/s OR mean pressure gradient ≥40mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2/m2 body surface area OR

⁃ Peak velocity ≥4m/s OR mean pressure gradient ≥40mmHg WITH aortic valve area \>1.0 - ≤1.2cm2 OR \>0.6 - ≤0.7cm2/m2 body surface area AND high sex specific calcium score\* OR

⁃ Peak Velocity ≥3.5m/s - 3.9m/s AND mean pressure gradient \<40 mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2/m2 body surface area AND high sex specific calcium score\* \*Sex specific high calcium scores (Agatston units): \>1200 females; \>2000 males

• The responsible clinician feels that either ongoing surveillance or early AVR are appropriate.

• Regarded by the treating cardiologist to be suitable for AVR (surgical or TAVI) with an acceptable risk

• Willing to provide informed consent and be randomised to early AVR or expectant management

• An ability to understand one of the written languages that the study has provided written and visual materials in, or the availability of a translator to explain the study documentation

Locations
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Adelaide
Royal Adelaide Hospital
RECRUITING
Adelaide
Prince Charles Hospital
RECRUITING
Chermside
Monash Health
RECRUITING
Clayton
Townsville Hospital
RECRUITING
Douglas
Lyell McEwin Hospital
RECRUITING
Elizabeth Vale
Northern Hospital
RECRUITING
Epping
Canberra Hospital
RECRUITING
Garran
University Hospital Geelong
RECRUITING
Geelong
Royal Hobart Hospital
RECRUITING
Hobart
Nepean Hospital
RECRUITING
Kingswood
Liverpool Hospital
RECRUITING
Liverpool
John Hunter Hospital
RECRUITING
New Lambton Heights
Fiona Stanley Hospital
RECRUITING
Perth
Royal Perth Hospital
RECRUITING
Perth
The Gold Coast Hospital
RECRUITING
Southport
Royal North Shore Hospital
RECRUITING
St Leonards
Royal Darwin Hospital
RECRUITING
Tiwi
Westmead Hospital
RECRUITING
Westmead
Wollongong Hospital
RECRUITING
Wollongong
Belgium
Sint-Jan Hospital
RECRUITING
Bruges
Ziekenhuis Oost-Limburg
RECRUITING
Genk
University Hospital of Brussels
RECRUITING
Jette
Netherlands
Frisius Medical Center
RECRUITING
Leeuwarden
Radboud University Medical Center
RECRUITING
Nijmegen
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Dunedin Hospital
RECRUITING
Dunedin
Serbia
Institute of Cardiovascular Diseases
RECRUITING
Kamenitz
Spain
Hospital Germans Trias
RECRUITING
Barcelona
University Hospital of Navarra
RECRUITING
Pamplona
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Aintree University Hospital
RECRUITING
Aintree
Wansbeck General Hospital
RECRUITING
Ashington
University Hospital Ayr
RECRUITING
Ayr
Barnsley Hospital NHS Foundation Trust
RECRUITING
Barnsley
Basildon University Hospital
RECRUITING
Basildon
Basingstoke and North Hampshire Hospital
RECRUITING
Basingstoke
Queen Elizabeth Hospital
RECRUITING
Birmingham
Blackpool Victoria Hospital
RECRUITING
Blackpool
Glan Clwyd Hospital
RECRUITING
Bodelwyddan
Royal Sussex County Hospital
RECRUITING
Brighton
North Cumbria Integrated Care
RECRUITING
Carlisle
Chesterfield Royal Hospital
RECRUITING
Chesterfield
University Hospital Coventry &amp; Warwickshire
RECRUITING
Coventry
County Durham and Darlington NHS Foundation Trust
RECRUITING
Darlington
Doncaster Royal Infirmary
RECRUITING
Doncaster
Dorset County Hospital
WITHDRAWN
Dorchester
Russells Hall Hospital
RECRUITING
Dudley
Ninewells Hospital
RECRUITING
Dundee
University Hospital of North Durham
RECRUITING
Durham
The Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Royal Devon & Exeter Hospital
RECRUITING
Exeter
Gateshead Health NHS Foundation Trust
RECRUITING
Gateshead
Glasgow Royal Infirmary
RECRUITING
Glasgow
Golden Jubilee National Hospital
RECRUITING
Glasgow
Queen Elizabeth University Hospital
RECRUITING
Glasgow
Gloucestershire Hospitals NHS Foundation
RECRUITING
Gloucester
Wycombe Hospital
RECRUITING
High Wycombe
Huddersfield Royal Infirmary
RECRUITING
Huddersfield
Raigmore Hospital
RECRUITING
Inverness
West Middlesex University Hospital
RECRUITING
Isleworth
Airedale General Hospital
RECRUITING
Keighley
Kettering General Hospital
RECRUITING
Kettering
University Hospital Crosshouse
RECRUITING
Kilmarnock
Leeds General Infirmary
RECRUITING
Leeds
University Hospitals Leicester, Glenfield
RECRUITING
Leicester
Lincoln County Hospital
RECRUITING
Lincoln
Liverpool Heart and Chest Hospital
RECRUITING
Liverpool
Royal Liverpool Hospital
NOT_YET_RECRUITING
Liverpool
Royal Liverpool Hospital
RECRUITING
Liverpool
Chelsea and Westminster Hospital
RECRUITING
London
Cleveland Clinic London Hospital
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
St George's Hospital
RECRUITING
London
St Thomas' Hospital
RECRUITING
London
University Hospital Lewisham
RECRUITING
London
Maidstone & Tunbridge Wells Hospital
RECRUITING
Maidstone
North Manchester General Hospital
RECRUITING
Manchester
Wythenshawe Hospital
RECRUITING
Manchester
The James Cook University Hospital
RECRUITING
Middlesbrough
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Norfolk and Norwich University Hospital
RECRUITING
Norwich
Kings Mill Hospital
RECRUITING
Nottingham
Queens Medical Centre
RECRUITING
Nottingham
George Eliot Hospital
RECRUITING
Nuneaton
Royal Alexandra Hospital
RECRUITING
Paisley
Derriford Hospital
RECRUITING
Plymouth
Poole Hospital
RECRUITING
Poole
Queen Alexandra Hospital
RECRUITING
Portsmouth
Scunthorpe General Hospital
RECRUITING
Scunthorpe
Northern General Hospital
RECRUITING
Sheffield
Southampton General Hospital
RECRUITING
Southampton
Forth Valley Royal Hospital
RECRUITING
Stirling
Stepping Hill Hospital
RECRUITING
Stockport
North Tees and Hartlepool NHS Foundation Trust
RECRUITING
Stockton-on-tees
South Tyneside and Sunderland NHS Foundation Trust
RECRUITING
Sunderland
Morriston Hospital
RECRUITING
Swansea
Musgrove Park Hospital
RECRUITING
Taunton
Torbay Hospital
RECRUITING
Torquay
Royal Cornwall Hospital
RECRUITING
Truro
Pinderfields Hospital
RECRUITING
Wakefield
Walsall Manor Hospital
RECRUITING
Walsall
South Warwickshire University NHS Foundation Trust
RECRUITING
Warwick
Watford General Hospital
RECRUITING
Watford
Sandwell General Hospital
RECRUITING
West Bromwich
New Cross Hospital
RECRUITING
Wolverhampton
Worcester Acute Hospitals NHS FT
RECRUITING
Worcester
Yeovil District Hospital
WITHDRAWN
Yeovil
Contact Information
Primary
Carla Richardson
easyas@leicester.ac.uk
+44 0116-229-7936
Backup
Michael Walters
easyas@leicester.ac.uk
Time Frame
Start Date: 2020-03-10
Estimated Completion Date: 2031-04-01
Participants
Target number of participants: 2844
Treatments
Active_comparator: Group A: Aortic valve replacement
Participants randomised to AVR will be investigated and managed according to local protocols and standard practice. Participants will be placed on the waiting list with the aim that surgery will be performed within 3 months, dependent on local hospitals' waiting lists.
No_intervention: Group B: Expectant management
Participants randomised to expectant management will continue to have regular monitoring of their condition in line with the procedures and standard practices of their hospital.
Sponsors
Collaborators: The University of Western Australia, University of Auckland, New Zealand, University Hospitals, Leicester
Leads: University of Leicester

This content was sourced from clinicaltrials.gov