Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)

Official title

Impact of Beta-blocker Administration on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement B-TAVR

Overview

This is a multi-centric, open-label, randomized trial to evaluate the safety and efficacy of temporary discontinuation of beta-blocker treatment in patients undergoing transcatheter aortic valve replacement.

Detailed description

Aortic stenosis (AS) is a common heart valve problem in older adults, affecting about 5% of people over 65. It leads to symptoms like fainting, chest pain, difficulty breathing, and heart failure, which can increase the risk of serious health issues and death.

Transcatheter Aortic Valve Replacement (TAVR) is a well-established treatment for severe AS, especially for patients who are at high risk for traditional open-heart surgery. TAVR is becoming more common and is now being used in younger and lower-risk patients due to its favorable outcomes.

Many people with severe AS also have other heart conditions, and beta-blockers (B-blockers) are commonly used to manage these issues. B-blockers help treat heart failure, irregular heartbeats, high blood pressure, and coronary artery disease. About 34% to 51% of AS patients use B-blockers, but these medications can also cause side effects like slow heart rate and low blood pressure.

The need for a permanent pacemaker is the most common complication after TAVR, occuring in 9% to 26% of patients. This is because TAVR can affect the heart's electrical system. B-blockers might increase the risk of needing a pacemaker because they can further slow down the heart's electrical signals.

To reduce this risk, doctors sometimes stop B-blockers around the time of TAVR. However, this practice lacks support from clinical trials or guidelines, and stopping B-blockers can increase the risk of fast heartbeats and chest pain.

This aim of the clinical trial is to study the impact of B-blocker administration among patients undergoing TAVR. The trial will assess the safety of B-blocker discontinuation (primary endpoint) and by determining the incidence of permanent pacemaker implantation after TAVR (secondary endpoint).

The results of the trial will provide important insights into the optimal management of B-blockers in patients undergoing TAVR, potentially improving patient outcomes and guiding clinical practice.

Interventions

• Other Transcatheter aortic valve replacement in the absence of B-blocker treatment
  Transcatheter aortic valve replacement (TAVR) is performed in patients that temporarily pause B-blocker treatment.
• Other Transcatheter aortic valve replacement
  Transcatheter aortic valve replacement (TAVR) is performed in patients that do not temporarily pause B-blocker treatment.

Primary outcome measures

• All-cause mortality [Time frame: At 30 days]
• Re-hospitalization due to heart failure [Time frame: At 30 days]
• Stroke Rate [Time frame: At 30 days]
• Severe arrhythmia requiring treatment [Time frame: At 30 days]

Secondary outcome measures (6)

• Permanent pacemaker implantation Rate [Time frame: At 30 days and 1 year]
• Stroke Rate [Time frame: At 30 days and 1 year]
• All-cause mortality [Time frame: At 30 days and 1 year]
• Cardiovascular mortality [Time frame: At 30 days and 1 year]
• Re-hospitalization due to heart failure [Time frame: At 30 days and 1 year]
• Severe arrhythmia requiring treatment [Time frame: At 30 days and 1 year]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 5 centers

• University Medical Center Freiburg — Bad Krozingen
• Kerckhoff-Klinik GmbH — Bad Nauheim
• Herz- und Diabeteszentrum NRW Universitätsklinik — Bad Oeynhausen
• Universitätsklinikum Giessen und Marburg GmbH — Giessen
• Universitätsklinikum Schleswig-Holstein AöR — Kiel

Switzerland · 4 centers

• University Hospital Basel — Basel
• Inselspital, Bern University Hospital — Bern
• Geneva University Hospitals — Geneva
• University Hospital of Zürich — Zurich

Austria · 2 centers

• Medical University of Graz — Graz
• University Hospital Salzburg — Salzburg

Identifiers

NCT: NCT06472934 · 2024-00728; kt23Nestelberger2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗