What side effects are associated with this type of intervention?

Beta-blockers, commonly used after Coronary Artery Bypass Surgery to reduce heart rate and blood pressure, can cause side effects such as bradycardia, hypotension, fatigue, dizziness, and gastrointestinal disturbances. They may also induce bronchospasm in patients with asthma or COPD. Abrupt withdrawal of beta-blockers can lead to rebound hypertension and tachycardia, necessitating careful management during discontinuation.

What other types of research exist?

Promising alternatives to beta-blocker withdrawal for CABG patients include: 1. Statins: Statins have been shown to reduce postoperative atrial fibrillation and improve overall cardiovascular outcomes. 2. Amiodarone: This antiarrhythmic drug is effective in preventing postoperative atrial fibrillation and reducing cardiovascular morbidity. 3. Colchicine: Known for its anti-inflammatory properties, colchicine has been found to reduce the incidence of postoperative atrial fibrillation. 4. N-acetylcysteine: This antioxidant has shown potential in reducing postoperative atrial fibrillation when used in combination with beta-blockers. 5. Sotalol: A beta-blocker with additional antiarrhythmic properties, sotalol is effective in preventing postoperative atrial fibrillation. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

← Back to Search

Beta-blocker

Stopping Beta-Blockers After Coronary Artery Bypass Surgery (DROP-BB Trial)

Q: What prior FDA approvals exist?

Beta-blockers, such as metoprolol, carvedilol, and propranolol, have been approved by the FDA for use in managing patients undergoing Coronary Artery Bypass Surgery (CABG). These medications are utilized to reduce heart rate, decrease blood pressure, and lower myocardial oxygen demand, which helps in minimizing the risk of perioperative cardiac events. The use of beta-blockers in the perioperative period is aimed at improving surgical outcomes and reducing complications associated with CABG.

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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 more

Awards & 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

0 / 3Eligibility criteria met

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.