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Coronary Artery DiseasePhase 4BEEFBURGERNCT04788186

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

A Phase 4 study testing De-prescribe beta blocker therapy in people with Coronary Artery Disease and Acute Myocardial Infarction, run by University of Saskatchewan at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
De-prescribe beta blocker therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteCanada
Study dates
23 Aug 2021to 31 Aug 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jay Shavadia, MD contact

3069862260

jss372@usask.ca

Natasha B Mostat, MSc contact

3063215708

natasha.boyes@usask.ca

Canada1 site, 1 recruiting

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

    Jay Shavadia, MD, 3069862260, jss372@usask.ca

    Jay Shavadia, MD;MRCP(UK)

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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).

Being tested
De-prescribe beta blocker therapy
Keywords
Beta Blocker drugs, coronary artery bypass graft, CABG, De-prescription
Medical subject headings
Coronary Artery Disease, Coronary Stenosis, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • De-prescribe beta blocker therapyDrug

    Also called De-prescription

    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
Study groups in NCT04788186
Study groupRoleWhat they receive
Continue beta blocker therapyNo interventionParticipants in this arm will continue their beta blocker therapy as per their usual clinical care
De-prescribe beta blocker therapyExperimentalBeta blocker therapy will be de-prescribed in this arm
Receives: Drug: De-prescribe beta blocker therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of all-cause mortality

    All-cause death includes death resulting from both cardiovascular and non-cardiovascular causes.

    Measured: 3 years

  2. Rate of spontaneous myocardial infarction

    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

    Measured: 3 Years

  3. Rate of stroke

    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)

    Measured: 3 Years

  4. Rate of hospitalizations for heart failure

    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.

    Measured: 3 Years

  5. Rate of cardiac arrhythmia

    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

    Measured: 3 Years

  6. Rate of syncope or need for permanent pacemaker

    Syncope suspicious for cardiac etiology requiring either hospitalization for ≥ 24 hours or needing an implantable monitoring device (such as loop recorder) or permanent pacemaker

    Measured: 3 Years

  7. Rate of recurrent myocardial ischemia

    Hospitalization or stay in the emergency department for ≥ 24 hours for myocardial ischemia or requiring unplanned revascularization

    Measured: 3 Years

Secondary outcomes (3)

  1. Change in patient reported quality of life (QoL) using Euro Qol (EQ) 5D questionnaire

    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).

    Measured: 3 years

  2. Change in patient reported quality of life using Short Form (SF) 36 questionnaire

    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.

    Measured: 3 years

  3. Change in the patient reported angina score using the Seattle Angina Questionnaire (SAQ)

    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).

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2021
  2. Study start23 Aug 2021
  3. Primary completion31 Aug 2024 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
open-label, randomized pilot comparison
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04788186
Sponsor's protocol ID
UofS REB Bio#2639
Acronym
BEEFBURGER
Status last verified
Nov 2022
First submitted
19 Feb 2021
Last updated
9 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Macle L, Cairns J, Leblanc K, Tsang T, Skanes A, Cox JL, Healey JS, Bell A, Pilote L, Andrade JG, Mitchell LB, Atzema C, Gladstone D, Sharma M, Verma S, Connolly S, Dorian P, Parkash R, Talajic M, Nattel S, Verma A; CCS Atrial Fibrillation Guidelines Committee. 2016 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation. Can J Cardiol. 2016 Oct;32(10):1170-1185. doi: 10.1016/j.cjca.2016.07.591. Epub 2016 Sep 6.

    PubMed 27609430

  • Gillis AM, Skanes AC; CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society atrial fibrillation guidelines 2010: implementing GRADE and achieving consensus. Can J Cardiol. 2011 Jan-Feb;27(1):27-30. doi: 10.1016/j.cjca.2010.11.003.

    PubMed 21329859

  • Thaper A, Kulik A. Rationale for administering beta-blocker therapy to patients undergoing coronary artery bypass surgery: a systematic review. Expert Opin Drug Saf. 2018 Aug;17(8):805-813. doi: 10.1080/14740338.2018.1504019. Epub 2018 Jul 27.

    PubMed 30037300

  • Vaishnava P, Eagle KA. Surgery. beta-Blockers--still a trusted ally or time for retirement? Nat Rev Cardiol. 2014 Sep;11(9):502-3. doi: 10.1038/nrcardio.2014.112. Epub 2014 Jul 29.

    PubMed 25072904

  • Rossello X, Pocock SJ, Julian DG. Long-Term Use of Cardiovascular Drugs: Challenges for Research and for Patient Care. J Am Coll Cardiol. 2015 Sep 15;66(11):1273-1285. doi: 10.1016/j.jacc.2015.07.018.

    PubMed 26361160

  • Park JJ, Kim SH, Kang SH, Yoon CH, Cho YS, Youn TJ, Chae IH, Choi DJ. Effect of beta-Blockers Beyond 3 Years After Acute Myocardial Infarction. J Am Heart Assoc. 2018 Mar 3;7(5):e007567. doi: 10.1161/JAHA.117.007567.

    PubMed 29502101

  • Puymirat E, Riant E, Aissaoui N, Soria A, Ducrocq G, Coste P, Cottin Y, Aupetit JF, Bonnefoy E, Blanchard D, Cattan S, Steg G, Schiele F, Ferrieres J, Juilliere Y, Simon T, Danchin N. beta blockers and mortality after myocardial infarction in patients without heart failure: multicentre prospective cohort study. BMJ. 2016 Sep 20;354:i4801. doi: 10.1136/bmj.i4801.

    PubMed 27650822

  • Dondo TB, Hall M, West RM, Jernberg T, Lindahl B, Bueno H, Danchin N, Deanfield JE, Hemingway H, Fox KAA, Timmis AD, Gale CP. beta-Blockers and Mortality After Acute Myocardial Infarction in Patients Without Heart Failure or Ventricular Dysfunction. J Am Coll Cardiol. 2017 Jun 6;69(22):2710-2720. doi: 10.1016/j.jacc.2017.03.578.

    PubMed 28571635

  • Shavadia JS, Holmes DN, Thomas L, Peterson ED, Granger CB, Roe MT, Wang TY. Comparative Effectiveness of beta-Blocker Use Beyond 3 Years After Myocardial Infarction and Long-Term Outcomes Among Elderly Patients. Circ Cardiovasc Qual Outcomes. 2019 Jul;12(7):e005103. doi: 10.1161/CIRCOUTCOMES.118.005103. Epub 2019 Jul 9.

    PubMed 31284739

  • Shavadia JS, Zheng Y, Green JB, Armstrong PW, Westerhout CM, McGuire DK, Cornel JH, Holman RR, Peterson ED. Associations between beta-blocker therapy and cardiovascular outcomes in patients with diabetes and established cardiovascular disease. Am Heart J. 2019 Dec;218:92-99. doi: 10.1016/j.ahj.2019.09.013. Epub 2019 Oct 20.

    PubMed 31715435

  • Tsujimoto T, Sugiyama T, Shapiro MF, Noda M, Kajio H. Risk of Cardiovascular Events in Patients With Diabetes Mellitus on beta-Blockers. Hypertension. 2017 Jul;70(1):103-110. doi: 10.1161/HYPERTENSIONAHA.117.09259. Epub 2017 May 30.

    PubMed 28559400

  • Bangalore S, Steg G, Deedwania P, Crowley K, Eagle KA, Goto S, Ohman EM, Cannon CP, Smith SC, Zeymer U, Hoffman EB, Messerli FH, Bhatt DL; REACH Registry Investigators. beta-Blocker use and clinical outcomes in stable outpatients with and without coronary artery disease. JAMA. 2012 Oct 3;308(13):1340-9. doi: 10.1001/jama.2012.12559.

    PubMed 23032550

  • da Graca B, Filardo G, Sass DM, Edgerton JR. Preoperative beta-Blockers for Isolated Coronary Artery Bypass Graft. Circ Cardiovasc Qual Outcomes. 2018 Dec;11(12):e005027. doi: 10.1161/CIRCOUTCOMES.118.005027. No abstract available.

    PubMed 30557046

  • Bjorklund E, Nielsen SJ, Hansson EC, Karlsson M, Wallinder A, Martinsson A, Tygesen H, Romlin BS, Malm CJ, Pivodic A, Jeppsson A. Secondary prevention medications after coronary artery bypass grafting and long-term survival: a population-based longitudinal study from the SWEDEHEART registry. Eur Heart J. 2020 May 1;41(17):1653-1661. doi: 10.1093/eurheartj/ehz714.

    PubMed 31638654

  • Kohsaka S, Miyata H, Motomura N, Imanaka K, Fukuda K, Kyo S, Takamoto S. Effects of Preoperative beta-Blocker Use on Clinical Outcomes after Coronary Artery Bypass Grafting: A Report from the Japanese Cardiovascular Surgery Database. Anesthesiology. 2016 Jan;124(1):45-55. doi: 10.1097/ALN.0000000000000901.

    PubMed 26517856

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing De-prescribe beta blocker therapy in people with Coronary Artery Disease and Acute Myocardial Infarction, run by University of Saskatchewan at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jay Shavadia, MD (3069862260, jss372@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of all-cause mortality (time frame: 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04788186, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.

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