MRI in Randomised Cohorts of Asymptomatic AS

NCT05178368 | Recruiting

• 1 other identifier: 0824
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic stenosis is narrowing of the aortic valve, and is the commonest type of valve disease requiring surgery. Current guidelines recommend waiting till patients develop symptoms (chest pain, breathlessness and dizzy spells/fainting) before possible open heart surgery to replace the valve is offered. However, studies using detailed 'MRI' scanning of the heart have shown that up to half of the patients already have 'scarring' in the heart by the time symptoms develop. Furthermore, scarring is not fully reversed even after surgery and is associated with worse outcome. This suggests that some patients are being offered treatment too late. Two randomised trials in the UK (EASY AS and EVOLVED) are currently investigating if valve replacement before symptoms will result in better survival. The aim of this study is to compare the effect of early valve replacement versus waiting for symptoms, on the amount of scarring in the heart. The investigators want to know if early treatment leads to less overall scarring at the end, and leads to better quality of life and recovery after surgery. The investigators will invite participants of the EASY AS and EVOLVED trials to have 1-2 MRI heart scans: at recruitment and 3 years after being randomly allocated to early aortic valve replacement vs 'watchful waiting'. The investigators will also assess the impact of the two treatment approaches on quality of life, disability-free survival (using questionnaires) and recovery after surgery. The results from this project will increase understanding of the results of the main trials, and lead to improved selection of patients with aortic stenosis who are likely to benefit from early surgery.

Conditions

Aortic Stenosis, Severe

Keywords

myocardial fibrosis; cardiac magnetic resonance imaging; late gadolinium enhancement

Outcome Measures

Primary Outcomes (1)

• Total amount of fibrosis (measured by LGE on MRI) in those randomised to early AVR vs standard care.

  Measured by percentage of late gadolinium enhancement on MRI, between those randomised to early AVR vs standard care.

  3 years

Secondary Outcomes (9)

• Differences in patient reported outcome measures (health related quality of life) between the two groups

  3 years

• Differences in patient reported outcome measures (patient perceptions of living with heart failure) between the two groups

  3 years

• Differences in patient reported outcome measures (in assessing functioning and disability in major life domains) between the two groups

  3 years

• Difference in peri-operative recovery between the two groups.

  30 days from date of surgery

• Differences in reverse remodelling (by left ventricular volume) between the two groups.

  3 years

Study Arms (2)

Early aortic valve replacement

Asymptomatic severe aortic stenosis patients randomised to early aortic valve replacement

Procedure: Surgical/ Transcatheter aortic valve replacement

Standard care

Asymptomatic severe aortic stenosis patients randomised to 'watchful waiting' until symptom onset.

Interventions

Surgical/ Transcatheter aortic valve replacement PROCEDURE

The choice of intervention will be made by the local clinical team. The timing of intervention will be determined by randomisation as part of the main EASY/EVOLVED trials

Early aortic valve replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asymptomatic severe aortic stenosis

You may qualify if:

• Willing to and able to consent
• Participant in an RCT randomising patients with asymptomatic severe AS to early AVR vs standard care
• Asymptomatic at the time of randomisation in the RCT
• Willingness to have 1-2 cardiac MRI scan(s)

You may not qualify if:

• Contra-indication to MRI.
• eGFR \<30.
• Severe claustrophobia (precluding MRI).

Sponsors & Collaborators

• University of Leicester: lead
• University of Edinburgh: collaborator

Study Sites (1)

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma collection for future ethically approved studies of biomarkers associated with fibrosis.

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Surgical Procedures, Operative; Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Anvesha Singh, Dr

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anvesha Singh, Dr

CONTACT

+44 116 252 3183; as707@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: January 5, 2022
• Study Start: July 28, 2021
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2031
• Last Updated: January 5, 2022

Record last verified: 2021-11

Locations

GB (1)