Aortic Stenosis
Conditions
Keywords
Transcatheter Aortic Valve Replacement, Beta-blockers
Brief summary
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
OTHERTranscatheter 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.
OTHERTranscatheter aortic valve replacement
Transcatheter aortic valve replacement (TAVR) is performed in patients that do not temporarily pause B-blocker treatment.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe arrhythmia requiring treatment | At 30 days | 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). |
| All-cause mortality | At 30 days | 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). |
| Re-hospitalization due to heart failure | At 30 days | 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. |
| Stroke Rate | At 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular mortality | At 30 days and 1 year | 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 |
| Severe arrhythmia requiring treatment | At 30 days and 1 year | 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). |
| Re-hospitalization due to heart failure | At 30 days and 1 year | 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. |
| Permanent pacemaker implantation Rate | At 30 days and 1 year | To analyse the efficacy of B-blocker discontinuation, the incidence of permanent pacemaker implantation is assessed within 30 days and 1 year after TAVR. |
| Stroke Rate | At 30 days and 1 year | The incidence of stroke is assessed within 30 days and 1 year after TAVR. |
| All-cause mortality | At 30 days and 1 year | The all-cause mortality is assessed within 30 days and 1 year after TAVR. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health economic assessment | At 30 days and 1 year | An assessment of the impact on health economic is performed, which includes information regarding the length of intensive care unit stay, length of hospital stay, rate of pacemaker implantation, and results of the Kansas City Cardiomyopathy quality of life Questionnaire (KCCQ-12) which ranges from 0 to 100 with higher scores indicating better health status and quality of life, while lower scores suggest more severe symptoms and poorer quality of life. |
Countries
Austria, Germany, Switzerland
Contacts
Primary ContactNicole Gilgen, Dr. med.
Backup ContactThomas Nestelberger, PD Dr.
Outcome results
None listed