Evaluating the effects of stopping beta-blockers during heart valve replacement
Impact of Beta-blocker Administration on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement B-TAVR
This study is testing if stopping beta-blockers before heart valve replacement can help prevent complications for adults with severe aortic stenosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 498 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 11 sites (Graz and 10 other locations) |
| Trial ID | NCT06472934 on ClinicalTrials.gov |
What this trial studies
This multi-centric, open-label, randomized trial investigates the safety and efficacy of temporarily discontinuing beta-blocker treatment in patients undergoing transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis. The study aims to determine whether stopping beta-blockers can reduce the risk of complications, such as the need for a permanent pacemaker, which can arise from the interaction between TAVR and the heart's electrical system. Eligible participants are adults over 18 years old who have been on beta-blocker therapy for at least one month prior to the study. The trial will compare outcomes between patients who continue beta-blocker treatment and those who do not during the TAVR procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with severe symptomatic aortic stenosis who are scheduled for elective TAVR and have been on beta-blocker therapy for at least one month.
Not a fit: Patients who are hemodynamically unstable, have prior pacemaker implantation, or are participating in another investigational study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize treatment protocols for patients undergoing TAVR, potentially reducing complications and improving outcomes.
How similar studies have performed: While the approach of discontinuing beta-blockers during TAVR lacks extensive clinical trial support, it is a novel investigation that addresses a significant gap in current treatment guidelines.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent must be signed by the subject prior to any study intervention. * Adult patients (\> 18 years) with severe symptomatic aortic stenosis eligible and scheduled for elective TAVR and are able to give consentand are able to give consent * Indication for B-blocker therapy with a prior treatment duration of at least 1 month before inclusion. Exclusion Criteria: * Emergency or urgent indication for TAVR. * Hemodynamically unstable patients receiving inotropic medication. * Prior permanent pacemaker implantation. * Existing indication for pacemaker implantation. * Hemodynamic relevant left ventricular outflow tract obstruction. * Prior intolerance of B-blocker medication. * Life expectancy \< 1 year. * Known or suspected non-compliance, drug, or alcohol abuse. * Inability to give consent, or follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. * Being in a dependent relationship with the trial site * Participation in another study with investigational drug within the 30 days preceding and during the present study. * Previous enrolment into the current study. * Pregnancy or breast feeding women
Where this trial is running
Graz and 10 other locations
- Medical University of Graz — Graz, Austria (Recruiting)
- University Hospital Salzburg — Salzburg, Austria (Recruiting)
- University Medical Center Freiburg — Bad Krozingen, Germany (Recruiting)
- Kerckhoff-Klinik GmbH — Bad Nauheim, Germany (Recruiting)
- Herz- und Diabeteszentrum NRW Universitätsklinik — Bad Oeynhausen, Germany (Recruiting)
- Universitätsklinikum Giessen und Marburg GmbH — Giessen, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein AöR — Kiel, Germany (Recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
- Inselspital, Bern University Hospital — Bern, Switzerland (Recruiting)
- Geneva University Hospitals — Geneva, Switzerland (Recruiting)
- University Hospital of Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Thomas Nestelberger, PD Dr. — University Hospital Basel, Department of Cardiology & Cardiovascular Research Institute Basel (CRIB)
- Study coordinator: Nicole Gilgen, Dr. med.
- Email: Nicole.Gilgen@usb.ch
- Phone: +41 61 328 74 23
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.