Impact of Beta-blocker Administration on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement B-TAVR
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 498
- Locations
- 22
- Primary Endpoint
- All-cause mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: 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).
Severe arrhythmia requiring treatment
Time Frame: 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).
Re-hospitalization due to heart failure
Time Frame: 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
Time Frame: 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 Outcomes
- Re-hospitalization due to heart failure(At 30 days and 1 year)
- Stroke Rate(At 30 days and 1 year)
- Cardiovascular mortality(At 30 days and 1 year)
- Permanent pacemaker implantation Rate(At 30 days and 1 year)
- All-cause mortality(At 30 days and 1 year)
- Severe arrhythmia requiring treatment(At 30 days and 1 year)