Clinical trial NCT06472934: Impact of Beta-blocker on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement (B-TAVR)
Official title: Impact of Beta-blocker Administration on Outcome Among Patients Undergoing Transcatheter Aortic Valve Replacement B-TAVR
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Keywords: Transcatheter Aortic Valve Replacement
Beta-blockers
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.
* 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 follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* 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

Primary outcomes:
measure: All-cause mortality
timeFrame: At 30 days
measure: Re-hospitalization due to heart failure
timeFrame: At 30 days
measure: Stroke Rate
timeFrame: At 30 days
measure: Severe arrhythmia requiring treatment
timeFrame: At 30 days
Secondary outcomes:
measure: Permanent pacemaker implantation Rate
timeFrame: At 30 days and 1 year
measure: Stroke Rate
timeFrame: At 30 days and 1 year
measure: All-cause mortality
timeFrame: At 30 days and 1 year
measure: Cardiovascular mortality
timeFrame: At 30 days and 1 year
measure: Re-hospitalization due to heart failure
timeFrame: At 30 days and 1 year
measure: Severe arrhythmia requiring treatment
timeFrame: At 30 days and 1 year
Other outcomes:
measure: Health economic assessment
timeFrame: At 30 days and 1 year
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital, Bern University Hospital
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Zürich
country: Switzerland
facility: University Hospital of Zürich
Study officials:
affiliation: University Hospital Basel, Department of Cardiology & Cardiovascular Research Institute Basel (CRIB)
name: Thomas Nestelberger, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: