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Beta-blocker
Stopping Beta-Blockers After Coronary Artery Bypass Surgery (DROP-BB Trial)
N/A
Recruiting
Led By Arnar Geirsson, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who underwent coronary artery bypass graft (CABG) surgery at Yale New Haven Hospital who presented to 1-month postoperative visit with ejection fraction >50% and in sinus rhythm at the time of hospital discharge or enrollment.
Be older than 18 years old
Must not have
Those who underwent aorta + CABG surgery.
Those who underwent combined valve + CABG surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if stopping beta-blocker medication after heart bypass surgery can help patients exercise better and feel less tired, while still keeping them safe from serious heart and brain problems.
Who is the study for?
This trial is for patients who had coronary artery bypass surgery at Yale New Haven Hospital, showed up for their 1-month post-op visit, have a heart pumping strength (ejection fraction) over 50%, and were in normal heart rhythm when leaving the hospital or joining the study. It's not for those who had additional valve or aorta surgeries along with their bypass.
What is being tested?
The study is looking into what happens if you stop taking beta-blocker meds after having coronary artery bypass surgery. Patients are randomly chosen to either keep taking or stop their beta-blockers to see how it affects them.
What are the potential side effects?
Stopping beta-blockers suddenly can lead to increased heart rate, blood pressure changes, chest pain, and risk of heart complications. The exact side effects will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had CABG surgery at Yale New Haven Hospital, left with a good heart pump function, and a normal heart rhythm.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery on my aorta and bypass surgery.
Select...
I had surgery for both heart valve and bypass.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness
Secondary study objectives
Adherence to medication and adjudication of endpoint
Change in activity level measured using the Veterans Specific Activity Questionnaire(VSAQ)
Change in fatigue measured using the Fatigue Assessment Scale (FAS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Withdrawing of beta-blockersExperimental Treatment1 Intervention
Discontinuation of all BB, and medication changes will be made at the 1-month clinic visit. A cardiopulmonary exercise test (CPET) will be performed 1 month after the randomization (2 months after CABG).
Group II: Continuation of beta-blocker regimenActive Control1 Intervention
Participants will continue with current standard of care on current beta-blocker regimen
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Beta-blockers are commonly used in patients undergoing Coronary Artery Bypass Surgery (CABG) due to their ability to reduce heart rate, decrease blood pressure, and lower myocardial oxygen demand. These mechanisms are crucial as they help to minimize the risk of myocardial ischemia and arrhythmias during and after surgery.
By reducing the workload on the heart, beta-blockers contribute to stabilizing the cardiovascular system, which is essential for the recovery and long-term outcomes of CABG patients.
The effectiveness and safety of beta antagonist in burned patients: A systematic review and meta-analysis.
The effectiveness and safety of beta antagonist in burned patients: A systematic review and meta-analysis.
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,039,998 Total Patients Enrolled
Glenn Memorial FundUNKNOWN
Arnar Geirsson, MDPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my aorta and bypass surgery.I had surgery for both heart valve and bypass.I had CABG surgery at Yale New Haven Hospital, left with a good heart pump function, and a normal heart rhythm.
Research Study Groups:
This trial has the following groups:- Group 1: Continuation of beta-blocker regimen
- Group 2: Withdrawing of beta-blockers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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