Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis

Launched by ODENSE UNIVERSITY HOSPITAL · May 31, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of early surgery for patients with severe aortic valve stenosis who do not show any symptoms but have signs of heart problems. Aortic valve stenosis is a condition where the heart's aortic valve becomes narrowed, making it harder for the heart to pump blood. The study aims to determine if performing surgery sooner, rather than just monitoring the patient, can lead to better heart function and overall health.

To be eligible for this trial, participants must be between 18 and 85 years old and have severe aortic stenosis, which means their aortic valve area is very small and blood flow is significantly restricted. They should not have noticeable symptoms but must have certain indicators of heart stress, like increased pressure in the heart chambers. If someone joins the study, they can expect to be closely monitored and possibly receive either surgery or continued care without immediate surgery, depending on the trial's design. This research could help improve treatment options for patients with this condition in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Severe AS defined as
• • 1. aortic valve area (AVA) ≤1 cm2, AND
• • 2. Transvalvular maximum velocity (Vmax) ≥3.5 m/s AND
• • 3. AS severity evaluated severe by a heart valve team conference. In cases where severity is not unambiguous an integrative approach will be utilized combining echocardiographic markers of valve severity and LV function, and if necessary aortic valve calcification estimated by non-contrast CT.
• • 2. Considered to be asymptomatic (estimated by a consultant in cardiology) 3. Considered to be candidate for AVR (transcatheter AVR/surgical AVR) 4. Sign of increased LV filling pressures18 or reduced longitudinal LV systolic function
• • <!-- -->
• • 1. Left atrial volume index (LAVi) \> 34 ml/m2; OR
• • 2. ratio of early diastolic peak mitral inflow velocity (E) to early mitral annulus diastolic velocity (e') ratio E/e'avg\>13; OR
• • 3. Threefold elevation in NT-proBNP compared to the upper expected age and gender value. OR
• • 4. GLS\>-15 5. Age ≥18 years 6. Signed informed consent
• Exclusion Criteria:
• • 1. LVEF\<50%
• • 2. Very severe AS defined as Vmax\>5 m/s.
• • 3. Concomitant severe valvular disease other than AS
• • 4. Previous valvular surgery
• • 5. Estimated glomerular filtration rate\<30 ml/min/m2
• • 6. Dementia
• • 7. Women of childbearing potential
• • 8. Inability to provide informed consent
• • 9. Age\>85 years.
• • 10. Supravalvular or subvalvular AS