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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 5 центров

• 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

Швейцария · 4 центра

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

Австрия · 2 центра

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

Идентификаторы

NCT: NCT06472934 · 2024-00728; kt23Nestelberger2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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