Beta Blocker De-prescription Following Coronary Artery Bypass Graft Surgery (BEEFBURGER Trial). (BEEFBURGER)

November 8, 2022 updated by: Jay Shavadia, University of Saskatchewan

BEta Blocker dEprescription Following Coronary Artery Bypass Graft sURGERy: Feasibility and Safety Pilot (BEEFBURGER Trial)

Beta-blockers have the greatest cardiovascular impact in patients with reduced heart function/heart failure and in reducing the peri-operative risk of atrial fibrillation. In patients without these high-risk features treated with coronary artery bypass graft (CABG) surgery, their continued long-term role is unclear.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, non-inferiority, randomized comparison of beta-blocker continuation versus de-prescription at the 6-8 week follow-up following isolated and uncomplicated CABG at Royal University Hospital, Saskatoon.

Patients treated with isolated CABG (without valve repair/replacement) and discharged on a beta-blocker are eligible for recruitment if they have preserved systolic function (EF ≥45%) and no history of heart failure, atrial fibrillation/flutter, or an alternate compelling indication for beta-blocker therapy. After obtaining informed consent, eligible patients are randomly assigned at 6-8 weeks to one of the two treatment groups: continued beta-blocker therapy per their usual clinical care OR beta-blocker de-prescription as per the study protocol.

The primary objective of this study is to demonstrate recruitment feasibility for beta-blocker de-prescription 6-8 weeks following uncomplicated CABG. Exploratory outcomes include the composite of all-cause mortality, myocardial infarction, stroke, arrhythmia, and cardiovascular-related hospitalization (congestive heart failure, recurrent ischemia, arrhythmia [supraventricular including atrial fibrillation, and ventricular], syncope or need for pacemaker) over a 3-year follow up duration.

Other exploratory outcomes will include a change in the patient reported quality of life using the Short Form (SF) 36 and Euro Qol (EQ) 5D questionnaires and angina score using the Seattle Angina Questionnaire (SAQ).

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Recruiting
        • Royal University Hospital
        • Contact:
        • Principal Investigator:
          • Jay Shavadia, MD;MRCP(UK)
        • Sub-Investigator:
          • Abbas Khani-Hanjani, MD;FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years treated with index isolated CABG
  • Able to consent to study
  • On beta blocker therapy at the 6-8week visit
  • LV systolic function (≥45% assessed within 6months of CABG date)

Exclusion Criteria:

  • Prior heart failure with reduced ejection fraction (LVEF <45%)
  • Pre- or peri-operative atrial fibrillation or flutter
  • Peri-CABG stroke
  • Unable to follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Continue beta blocker therapy
Participants in this arm will continue their beta blocker therapy as per their usual clinical care
Experimental: De-prescribe beta blocker therapy
Beta blocker therapy will be de-prescribed in this arm
Drug: De-prescribe beta blocker therapy

Participants will be de-prescribed for beta-blocker therapy.

De-prescription will be performed as follows:

  • Half of pre-randomization dose for the first 3 days, then
  • Half of the above dose for the next 3 days, then discontinue
Other Names:
  • De-prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of all-cause mortality
Time Frame: 3 years
All-cause death includes death resulting from both cardiovascular and non-cardiovascular causes.
3 years
Rate of spontaneous myocardial infarction
Time Frame: 3 Years

All spontaneous (type 1) myocardial infarctions as per the Universal MI definition.

Typical rise or fall of biochemical markers of myocardial necrosis to greater than twice the upper limit of normal (ULN). If markers were already elevated, and have not reached their peak then further elevation of a marker ≥50% of a previous value and >2X ULN is required. If biomarkers are stable or decreasing then a re-elevation of ≥ 20% and > 2X ULN is required.

All also require meeting at least one of the following criteria:

  • Ischemic symptoms
  • Development of new pathological Q waves (distinct from index STEMI)
  • ECG changes of new ischemia or
  • Pathological evidence of MI
3 Years
Rate of stroke
Time Frame: 3 Years

On the basis of CT or MRI imaging or autopsy, stroke is classified as:

  • Ischemic stroke (including hemorrhagic transformation of ischemic stroke)
  • Hemorrhagic stroke (including intracerebral / intraparenchymal hemorrhage and subarachnoid hemorrhage)
  • Undetermined stroke (no imaging or autopsy available)
3 Years
Rate of hospitalizations for heart failure
Time Frame: 3 Years

Physician decision to treat heart failure with intravenous furosemide, if already on oral diuretics (for an alternate indication other than prior congestive heart failure (CHF*), a 50% dose increase) with New York Heart Association class III or IV symptoms plus at least one of the following:

  • Presence of pulmonary edema or pulmonary vascular congestion on chest radiograph thought to be due to heart failure
  • Rales reaching above the lower 1/3 of the lung fields thought to be due to heart failure or

  • Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) >18 mm Hg

    • Patients with a prior history of heart failure are not eligible for randomization.
3 Years
Rate of cardiac arrhythmia
Time Frame: 3 Years

Supraventricular (excluding atrial fibrillation)

  • Includes all forms of Supraventricular tachycardia (SVT) such as atrioventricular reentry tachycardia (AVRT), atrioventricular node reentry tachycardia (AVNRT), atrial tachycardia
  • Atrial fibrillation

Any new finding of clinical atrial fibrillation lasting greater than 30 seconds plus at least one of the following:

  • ECG
  • Rhythm strip
  • If ECG document or Holter report is unavailable, clear physician diagnosis Ventricular Non-sustained or sustained ventricular tachycardia or ventricular fibrillation
3 Years
Rate of syncope or need for permanent pacemaker
Time Frame: 3 Years
Syncope suspicious for cardiac etiology requiring either hospitalization for ≥ 24 hours or needing an implantable monitoring device (such as loop recorder) or permanent pacemaker
3 Years
Rate of recurrent myocardial ischemia
Time Frame: 3 Years
Hospitalization or stay in the emergency department for ≥ 24 hours for myocardial ischemia or requiring unplanned revascularization
3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient reported quality of life (QoL) using Euro Qol (EQ) 5D questionnaire
Time Frame: 3 years

Change in scores will be used to describe differences in the quality of life between the two study arms (Continuation Vs De-prescription).

The EQ-5D is a patient self-reported questionnaire scored from 0 (being the worst health state imaginable meaning worse outcome) to 100 (being the best health state imaginable meaning better outcome).
3 years
Change in patient reported quality of life using Short Form (SF) 36 questionnaire
Time Frame: 3 years

Change in scores will be used to describe differences in the quality of life between the two study arms (Continuation Vs De-prescription).

The SF-36 consists of eight scaled scores. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability (meaning worse outcome). The higher the score the less disability (meaning better outcome) i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
3 years
Change in the patient reported angina score using the Seattle Angina Questionnaire (SAQ)
Time Frame: 3 years
The Seattle Angina Questionnaire is the most sensitive, specific, and responsive health-related quality of life instrument for coronary artery disease. The SAQ is a self-administered, disease-specific measure for patients with CAD that is valid, reproducible, and sensitive to clinical change. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Canadian VIGOUR Centre

Investigators

  • Study Chair: Haissam Haddad, MD, FRCPC, University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

August 31, 2025

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

March 6, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UofS REB Bio#2639

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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