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Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS

Study acronym: EVoLVeD
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv13
  2. Minor Study Identification, Study Status, Oversightv12
  3. Minor Study Identification, Study Status, Oversightv11
  4. Minor Re-verified, no change to tracked fieldsv10
  5. Minor Completion date: Oct 1, 2024 to Jun 30, 2032v9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Primary completion date: Oct 1, 2024 to Jul 1, 2024v8
  2. Minor Trial status: Recruiting to Active, Not Recruiting Site details revisedv7 Show 1 more changeShow less
    • Site details revised
  3. Minor 2 versions Re-verified since Apr 27, 2021, no change to tracked fieldsv5-v6
  4. Notable Primary and study completion dates: Jul 1, 2022 to Oct 1, 2024v4
  5. Notable Primary and study completion dates: Dec 1, 2020 to Jul 1, 2022v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 1, 2017 to Jul 21, 2017v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2017 to Jul 21, 2017
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Aortic stenosis is the most common valvular disease in the Western world. It is caused by progressive narrowing of the aortic valve leading to increased strain on the heart muscle which has to work increasingly hard to pump blood through the narrowed valve. Over time the heart muscle thickens to generate more force, but eventually the heart fails leading to death if the valve is not replaced with an operation. No medical treatments exist to stop or reverse the heart valve narrowing. Current clinical guidelines suggest that an operation should be performed only when symptoms develop or the heart muscle is visibly weak on cardiac ultrasound scanning. However, symptoms can be difficult to interpret and in many patients the heart muscle has become irreversibly damaged and the heart fails to recover following surgery. Using MRI scans of the heart, the investigators have identified heart scarring which seems to develop as the heart muscle thickens. Several studies now show that people who have developed this scarring are more likely to suffer poor outcomes including death. The investigators have also identified clinical risks that predict the presence of scarring. The investigators propose a study where patients with severe aortic stenosis but no indications for valve replacement as per current guidelines are assessed for those clinical risks. If a participant's risk of having scarring is higher they will undergo a cardiac MRI scan. If scarring is present participants will be randomised to routine clinical care, or referral for valve replacement surgery. Participants with no evidence of scarring will be randomised routine care with study follow or not. The investigators of this study hypothesize that early surgery will lead to fewer complications and reduced risk of death compared to standard care.
Trial Details
NCT Number NCT03094143
Lead Sponsor University of Edinburgh
Collaborators: Sir Jules Thorn Charitable Trust
Conditions Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov