Effects of beta blockers on patients undergoing TAVI for aortic valve stenosis
Impact of Beta-blockers Among Patients Undergoing TAVI: a Randomized Multicenter Trial
This study is testing whether stopping or continuing beta-blocker medication helps adults undergoing heart valve surgery feel better and have fewer complications afterward.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 347 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 2 sites (Nicosia and 1 other locations) |
| Trial ID | NCT05721170 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of continuing or withdrawing beta-blocker medication in adults undergoing transcatheter aortic valve implantation (TAVI) for severe aortic valve stenosis. Participants will be randomly assigned to either continue or stop their beta-blocker treatment at least 72 hours before and 7 days after the procedure. The primary focus is on the rates of permanent pacemaker implantation within 7 days post-TAVI, while secondary outcomes include mortality, cardiogenic shock, and arrhythmias over a 12-month period. The study aims to clarify the role of beta-blockers in patients with severe valvulopathy undergoing TAVI.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe symptomatic aortic stenosis who are at high risk for surgical aortic valve replacement and currently receiving beta-blockers.
Not a fit: Patients who do not have severe symptomatic aortic stenosis or are not currently on beta-blocker therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize treatment protocols for patients undergoing TAVI, potentially reducing complications and improving outcomes.
How similar studies have performed: While the role of beta-blockers in valvulopathy is not fully understood, similar studies have explored their effects in heart failure and arrhythmias, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Study population Eligible patients are adults that whom TAVI is indicated as therapy for severe aortic valve stenosis and will be assigned randomly in a 1:1 ratio to either continue or withdraw the beta-blockers medication. Furthermore, they should satisfy all eligibility criteria (inclusion and exclusion). Inclusion criteria * Adults ≥18 years old. * Patient with severe symptomatic aortic stenosis defined by mean aortic gradient \> 40 mmHg or/and peak jet velocity \> 4.0 m/s or/and aortic valve area (AVA) \< 1cm2 or/and AVA indexed to body surface area (BSA) of \<0.6 cm2/m2. * Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of at least a cardiologist and surgeon. * Patients with anatomic characteristics suitable for TAVI based on the local Heart Team decision. * Patients receiving beta-blockers as a part of their indicated treatment plan. * Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up. * Patient has given written consent to participate in the trial. Exclusion criteria * A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, bivalirudin, clopidogrel, titanium, nickel, cobaltium, chromium, contrast media. * Patients with permanent pacemaker or defibrillator. * Ongoing infection, including active endocarditis. * Echocardiographic evidence of LV or LA thrombus. * The patient that has any contraindication for antithrombotic treatment. * Estimated life expectancy of less than 12 months. * Pregnancy and pre-perimenopause. * 2nd and 3rd degree atrioventricular (AV) block. * Bradycardia (\<50 beats per minute) at the electrocardiogram (ECG) on the screening/baseline visit. * Co-morbidity that excludes or significantly interferes with the follow-up visits. * Enrolment in another study that competes or interferes with this study.
Where this trial is running
Nicosia and 1 other locations
- Nicosia General Hospital — Nicosia, Cyprus (Recruiting)
- First Department of Cardiology, National and Kapodistrian University of Athens — Athens, Attica, Greece (Recruiting)
Study contacts
- Principal investigator: Leonidas Koliastasis, MD, MSc — National and Kapodistrian University of Athens
- Study coordinator: Leonidas Koliastasis, MD, MSc, PhD
- Email: lkoliastasis@gmail.com
- Phone: 6974270752
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.