NCT03094143: EVoLVeD

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

Active, enrolled NA Last updated 8 September 2025

What this trial tests

NA trial testing Aortic valve intervention in Aortic Valve Stenosis in 1,000 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 July 2017

Primary endpoint
1 July 2024

30 June 2032

Quick facts

Lead sponsor	University of Edinburgh
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,000
Start date	21 July 2017
Primary completion	1 July 2024
Estimated completion	30 June 2032
Sites	1 location across United Kingdom

Drugs / interventions tested

• Aortic valve intervention

Conditions studied

• Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
• Hypertrophy, Left Ventricular — all drugs for Hypertrophy, Left Ventricular →

Sponsor

University of Edinburgh

Who can join

18 and older, any sex, with Aortic Valve Stenosis or Hypertrophy, Left Ventricular. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 2021 ESC/EACTS Guidelines for the management of valvular heart disease.
   Vahanian A, Beyersdorf F, Praz F, Milojevic M, et al · · 2022 · cited 250× · PMID 34931612 · DOI 10.4244/eij-e-21-00009
2. Extracellular Myocardial Volume in Patients With Aortic Stenosis.
   Everett RJ, Treibel TA, Fukui M, Lee H, et al · · 2020 · cited 177× · PMID 31976869 · DOI 10.1016/j.jacc.2019.11.032
3. Imaging and Impact of Myocardial Fibrosis in Aortic Stenosis.
   Bing R, Cavalcante JL, Everett RJ, Clavel MA, et al · · 2019 · cited 177× · PMID 30732723 · DOI 10.1016/j.jcmg.2018.11.026
4. Myocardial Scar and Mortality in Severe Aortic Stenosis.
   Musa TA, Treibel TA, Vassiliou VS, Captur G, et al · · 2018 · cited 177× · PMID 30002099 · DOI 10.1161/circulationaha.117.032839
5. Progression of Hypertrophy and Myocardial Fibrosis in Aortic Stenosis: A Multicenter Cardiac Magnetic Resonance Study.
   Everett RJ, Tastet L, Clavel MA, Chin CWL, et al · · 2018 · cited 152× · PMID 29914867 · DOI 10.1161/circimaging.117.007451
6. Myocardial fibrosis: why image, how to image and clinical implications.
   Bing R, Dweck MR. · · 2019 · cited 89× · PMID 31649047 · DOI 10.1136/heartjnl-2019-315560
7. Timing of intervention in aortic stenosis: a review of current and future strategies.
   Everett RJ, Clavel MA, Pibarot P, Dweck MR. · · 2018 · cited 88× · PMID 30030337 · DOI 10.1136/heartjnl-2017-312304
8. Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED Randomized Clinical Trial.
   Loganath K, Craig NJ, Everett RJ, Bing R, et al · · 2025 · cited 83× · PMID 39466640 · DOI 10.1001/jama.2024.22730