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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
498
Transcatheter aortic valve replacement (TAVR) is performed in patients that temporarily pause B-blocker treatment.
Transcatheter aortic valve replacement (TAVR) is performed in patients that do not temporarily pause B-blocker treatment.
Medical University of Graz
Graz, Austria
RECRUITINGUniversity Hospital Salzburg
Salzburg, Austria
RECRUITINGAll-cause mortality
To analyse the safety of B-blocker discontinuation, the all-cause mortality, as part of a composite endpoint, is assessed within 30 days after transcatheter aortic valve replacement (TAVR).
Time frame: At 30 days
Re-hospitalization due to heart failure
To analyse the safety of B-blocker discontinuation, the incidence of re-hospitalization due to heart failure, as part of a composite endpoint, is assessed within 30 days after TAVR. Re-hospitalization due to heart failure is defined as an admission occurring after the index hospitalization or study enrollment, where new or worsening heart failure is the primary reason for a hospital stay exceeding 24 hours. This determination is based on symptoms and signs of heart failure, confirmed by diagnostic tests, and requires treatment with intravenous or mechanical heart failure therapies. This includes both primary (cardiac-related) and secondary (non-cardiac-related) causes.
Time frame: At 30 days
Stroke Rate
To analyse the safety of B-blocker discontinuation, the incidence of stroke, as part of a composite endpoint, is assessed within 30 days after TAVR.
Time frame: At 30 days
Severe arrhythmia requiring treatment
To analyse the safety of B-blocker discontinuation, the incidence of severe arrhythmia that requires treatment, as part of a composite endpoint, is assessed within 30 days after TAVR. Severe arrhythmia requiring treatment are e.g. new onset atrial fibrillation/flutter, ventricular tachycardia/ventricular fibrillation, new atrioventricular block (AB, first-, second- or third-degree), new left bundle branch block, new right bundle branch block, new severe bradycardia or tachycardia (\<40bpm or \>120bpm).
Time frame: At 30 days
Permanent pacemaker implantation Rate
To analyse the efficacy of B-blocker discontinuation, the incidence of permanent pacemaker implantation is assessed within 30 days and 1 year after TAVR.
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University Medical Center Freiburg
Bad Krozingen, Germany
RECRUITINGKerckhoff-Klinik GmbH
Bad Nauheim, Germany
RECRUITINGHerz- und Diabeteszentrum NRW Universitätsklinik
Bad Oeynhausen, Germany
RECRUITINGUniversitätsklinikum Giessen und Marburg GmbH
Giessen, Germany
RECRUITINGUniversitätsklinikum Schleswig-Holstein AöR
Kiel, Germany
RECRUITINGUniversity Hospital Basel
Basel, Switzerland
RECRUITINGInselspital, Bern University Hospital
Bern, Switzerland
RECRUITINGGeneva University Hospitals
Geneva, Switzerland
RECRUITING...and 1 more locations
Time frame: At 30 days and 1 year
Stroke Rate
The incidence of stroke is assessed within 30 days and 1 year after TAVR.
Time frame: At 30 days and 1 year
All-cause mortality
The all-cause mortality is assessed within 30 days and 1 year after TAVR.
Time frame: At 30 days and 1 year
Cardiovascular mortality
The cardiovascular mortality is assessed within 30 days and 1 year after TAVR. It is defined as either: * Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis),or other clear cardiovascular cause * Intraprocedural death * Sudden death * Death of unknown cause
Time frame: At 30 days and 1 year
Re-hospitalization due to heart failure
The incidence of re-hospitalization due to heart failure, as part of a composite endpoint, is assessed within 30 days and 1 year after TAVR. Re-hospitalization due to heart failure is defined as an admission occurring after the index hospitalization or study enrollment, where new or worsening heart failure is the primary reason for a hospital stay exceeding 24 hours. This determination is based on symptoms and signs of heart failure, confirmed by diagnostic tests, and requires treatment with intravenous or mechanical heart failure therapies. This includes both primary (cardiac-related) and secondary (non-cardiac-related) causes.
Time frame: At 30 days and 1 year
Severe arrhythmia requiring treatment
The incidence of severe arrhythmia that requires treatment, as part of a composite endpoint, is assessed within 30 days and 1 year after TAVR. Severe arrhythmia requiring treatment are e.g. new onset atrial fibrillation/flutter, ventricular tachycardia/ventricular fibrillation, new atrioventricular block (AB, first-, second- or third-degree), new left bundle branch block, new right bundle branch block, new severe bradycardia or tachycardia (\<40bpm or \>120bpm).
Time frame: At 30 days and 1 year