Early Aortic Valve Replacement for Patients With Asymptomatic Severe Aortic Stenosis
Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis
This study is testing if early aortic valve replacement can help people with severe aortic stenosis who don’t have symptoms but show early signs of heart problems, compared to just waiting for symptoms to appear.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1700 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense, Fyn) |
| Trial ID | NCT03972644 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of early aortic valve replacement (AVR) in patients who have asymptomatic severe aortic stenosis but show signs of subclinical left ventricular dysfunction. The research aims to determine whether performing surgery before the onset of symptoms can improve long-term outcomes compared to a watchful waiting approach. The study will evaluate patients based on specific echocardiographic markers and other indicators of left ventricular filling pressures. The goal is to provide insights into the timing of surgical intervention in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe aortic stenosis who are asymptomatic but exhibit signs of increased left ventricular filling pressures.
Not a fit: Patients who are symptomatic or do not meet the criteria for severe aortic stenosis will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved long-term outcomes and reduced mortality for patients with asymptomatic severe aortic stenosis.
How similar studies have performed: Previous studies have suggested potential benefits of early intervention in similar patient populations, although they were limited in size and scope.
Eligibility criteria
Show full inclusion / exclusion 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
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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
Where this trial is running
Odense, Fyn
- Odense University Hospital — Odense, Fyn, Denmark (Recruiting)
Study contacts
- Study coordinator: Jordi S Dahl, MD, PhD
- Email: jordi.dahl@rsyd.dk
- Phone: +4523823016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.