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Search / Trial NCT05178368

MRI in Randomised Cohorts of Asymptomatic AS

Launched by UNIVERSITY OF LEICESTER · Dec 16, 2021

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Myocardial Fibrosis Cardiac Magnetic Resonance Imaging Late Gadolinium Enhancement

ClinConnect Summary

This clinical trial is studying the effects of early surgery to replace the aortic valve in patients who have severe aortic stenosis but do not yet have symptoms. Aortic stenosis is a condition where the heart's aortic valve becomes too narrow, making it hard for the heart to pump blood. Current guidelines suggest waiting for symptoms like chest pain or breathlessness before considering surgery. However, researchers have found that many patients may already have damage to their heart even before symptoms appear. This trial aims to see if replacing the valve earlier, before symptoms develop, can reduce heart damage and improve recovery and quality of life after surgery.

To be eligible for this study, participants must be part of another trial that randomly assigns patients to either early surgery or standard care and must have severe aortic stenosis without symptoms at the time of randomization. They also need to be willing to undergo one or two MRI heart scans. During the study, participants will have their heart health monitored through these scans and will answer questions about their quality of life and recovery after surgery. This important research could help doctors better decide when to offer surgery to patients with aortic stenosis.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Willing to and able to consent
  • 2. Participant in an RCT randomising patients with asymptomatic severe AS to early AVR vs standard care
  • 3. Severe aortic stenosis, as defined by original trial's inclusion criteria
  • 4. Asymptomatic at the time of randomisation in the RCT
  • 5. Willingness to have 1-2 cardiac MRI scan(s)
  • Exclusion Criteria:
  • 1. Contra-indication to MRI.
  • 2. eGFR \<30.
  • 3. Severe claustrophobia (precluding MRI).

About University Of Leicester

The University of Leicester is a leading research institution in the UK, renowned for its commitment to advancing scientific knowledge and improving healthcare through innovative clinical trials. The university fosters a collaborative environment that integrates diverse disciplines, enabling the development of cutting-edge research initiatives aimed at addressing pressing medical challenges. With a focus on ethical practices and patient-centered outcomes, the University of Leicester is dedicated to enhancing clinical research methodologies and contributing to the advancement of medical sciences, ultimately striving to translate research findings into tangible health benefits for communities.

Locations

Leicester, Leicestershire, United Kingdom

Patients applied

0 patients applied

Trial Officials

Anvesha Singh, Dr

Principal Investigator

University of Leicester

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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