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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pausing group | Experimental | Subjects in the pausing group will stop their B-blocker medication 72h before the scheduled transcatheter aortic valve replacement (TAVR) procedure. Post-procedural B-blocker therapy will be resumed 72h after the procedure using the same type and dosage as prescribed before. |
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| Control group | Other | Subjects in the control group will keep their B-blocker medication in their prescribed dose during the scheduled TAVR procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter aortic valve replacement in the absence of B-blocker treatment | Other | Transcatheter aortic valve replacement (TAVR) is performed in patients that temporarily pause B-blocker treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| All-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). | 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. | 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. | 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). | At 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 30 days and 1 year |
| Stroke Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Health economic assessment | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Gilgen, Dr. med. | Contact | +41 61 328 74 23 | Nicole.Gilgen@usb.ch | |
| Thomas Nestelberger, PD Dr. | Contact | +41 61 328 74 74 | thomas.nestelberger@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Nestelberger, PD Dr. | University Hospital Basel, Department of Cardiology & Cardiovascular Research Institute Basel (CRIB) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Recruiting | Graz | 8036 | Austria |
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| Transcatheter aortic valve replacement | Other | Transcatheter aortic valve replacement (TAVR) is performed in patients that do not temporarily pause B-blocker treatment. |
|
The incidence of stroke is assessed within 30 days and 1 year after TAVR.
| At 30 days and 1 year |
| All-cause mortality | The all-cause mortality is assessed within 30 days and 1 year after TAVR. | 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:
| 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. | 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). | At 30 days and 1 year |
| At 30 days and 1 year |
| University Hospital Salzburg | Recruiting | Salzburg | 5020 | Austria |
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| University Medical Center Freiburg | Recruiting | Bad Krozingen | 79189 | Germany |
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| Kerckhoff-Klinik GmbH | Recruiting | Bad Nauheim | 61231 | Germany |
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| Herz- und Diabeteszentrum NRW Universitätsklinik | Recruiting | Bad Oeynhausen | 32545 | Germany |
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| Universitätsklinikum Giessen und Marburg GmbH | Recruiting | Giessen | 35392 | Germany |
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| Universitätsklinikum Schleswig-Holstein AöR | Recruiting | Kiel | 24105 | Germany |
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| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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| Inselspital, Bern University Hospital | Recruiting | Bern | 3010 | Switzerland |
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| Geneva University Hospitals | Recruiting | Geneva | 1205 | Switzerland |
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| University Hospital of Zürich | Recruiting | Zurich | 8091 | Switzerland |
|
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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