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De-Adoption of Beta-Blockers in Patients With Stable Ischemic Heart Disease (ABBREVIATE)

Primary Purpose

Stable Ischemic Heart Disease, Coronary Artery Disease, Beta-blocker Therapy

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Medical Assessment
Quality of Life Assessment
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Ischemic Heart Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age >21 years

  2. Documented Coronary Artery Disease (CAD) defined as:

    • Myocardial Infarction at least 6 months prior; or

    • Stable ischemic heart disease (defined using one of the following tests suggestive of significant coronary artery disease):

      i. Positive exercise stress test ii. Positive Nuclear perfusion scan iii. Positive exercise or pharmacologic echocardiographic stress test iv. Positive magnetic resonance imaging coronary perfusion scan v. Coronary computed tomographic angiography Angiogram with stenosis ≥ 70% (or left main coronary artery ≥ 50%) or significant function disease based or positive fractional flow reserve testing by CT (FFRCT); vi. Invasive coronary angiography with ≥ 70% (or left main coronary artery ≥ 50%) or significant function disease based or positive fractional flow reserve testing (FFR) or instant wave free ratio (IFR),

    • Previous Percutaneous Coronary Intervention (PCI, at least 6 months prior if revascularization is performed for an MI); or
    • Previous Coronary Artery Bypass Grafting (CABG, at least 6 months prior if revascularization is performed for an MI)
  3. Able and willing to provide informed consent

Exclusion Criteria:

  1. Left Ventricular Ejection Fraction < 40% or current hospitalization for heart failure
  2. Myocardial infarction <6 months prior to randomization
  3. Indication for β-blocker as determined by the treating physician (such as atrial or ventricular arrhythmias or ongoing angina not controlled by another agent)
  4. Uncontrolled hypertension or uncontrolled angina symptoms (per the Investigator's discretion)
  5. Non-compliance with medical therapy
  6. Life expectancy <1 year
  7. Participation in another trial related to β-blockers or other anti-anginal drugs

Sites / Locations

  • University of Alberta HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Continuation of Beta-Blockers

De-Adoption of Beta-Blockers

Arm Description

For patients already on β-blocker therapy, the treatment will be continued and titrated at the discretion of the patient's most responsible physician(s).

For patients on β-blocker therapy, medication will be tapered over 3-7 days to minimize the potential for withdrawal-related symptoms. A standardized angina treatment algorithm, which is independent of β-blocker use, will minimize any worsening of angina symptoms during drug withdrawal by utilizing other guideline recommended anti-anginal agents, such as calcium-channel blockers, long acting nitrates, or ivabradine. An anticipated 5% of patients allocated to this arm will not be able to tolerate discontinuation, however, patients will continue participation as per intention-to-treat principle. Background lifestyle measures and medical therapies will be recommended according to current Canadian guideline recommendations and individual patient profiles. Structured algorithms to achieve blood pressure goals that exclude the use of a β-blocker based on the Canadian Hypertension Education Program Guidelines will be provided.

Outcomes

Primary Outcome Measures

Composite of time to first all-cause death, non-fatal MI, or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization or heart failure over an estimated four years
Composite of time to first all-cause death, non-fatal MI, or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization or heart failure over an estimated four years

Secondary Outcome Measures

individual components of the primary objective (including all-cause death, non-fatal MI, or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization or HF)
individual components of the primary objective (including all-cause death, non-fatal MI, or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization or HF)
stroke
stroke
angina related quality of life
angina related quality of life as measured by the Seattle Angina Questionnaire
sexual function
sexual function as measured by the IIEF-5 and FSFI
new onset diabetes
new onset diabetes
drug withdrawal
stop/re-start dates
health care costs in each arm
health care costs in each arm

Full Information

First Posted
September 20, 2021
Last Updated
January 30, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05081999
Brief Title
De-Adoption of Beta-Blockers in Patients With Stable Ischemic Heart Disease
Acronym
ABBREVIATE
Official Title
De-Adoption βeta-Blockers in Patients With Stable Ischemic Heart Disease Without REduced LV Ejection Fraction, Ongoing Ischemia, or Arrhythmias: a pragmaTic randomizEd Trial With Blinded Endpoints
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with heart disease are often prescribed many medications and these patients may experience drug interactions or negative drug related side effects. With newer medications and treatments available, it is not well known whether older drugs, such as beta-blockers, are still an effective and safe option for treating heart disease. Some evidence suggests beta-blockers should be continued, whereas other evidence suggests beta-blockers might cause unnecessary harm. The study hopes to determine whether continuation or discontinuation of beta-blockers will affect long term cardiovascular outcomes. The study investigators will also examine how beta-blockers continuation or discontinuation affects several quality of life measures.
Detailed Description
Patients will be randomized to continue β-blocker therapy or discontinue β-blocker therapy. Patients will be followed remotely for approximately four years for adherence, events and outcomes assessments, and completion of multiple web-based quality of life questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Ischemic Heart Disease, Coronary Artery Disease, Beta-blocker Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuation of Beta-Blockers
Arm Type
Other
Arm Description
For patients already on β-blocker therapy, the treatment will be continued and titrated at the discretion of the patient's most responsible physician(s).
Arm Title
De-Adoption of Beta-Blockers
Arm Type
Other
Arm Description
For patients on β-blocker therapy, medication will be tapered over 3-7 days to minimize the potential for withdrawal-related symptoms. A standardized angina treatment algorithm, which is independent of β-blocker use, will minimize any worsening of angina symptoms during drug withdrawal by utilizing other guideline recommended anti-anginal agents, such as calcium-channel blockers, long acting nitrates, or ivabradine. An anticipated 5% of patients allocated to this arm will not be able to tolerate discontinuation, however, patients will continue participation as per intention-to-treat principle. Background lifestyle measures and medical therapies will be recommended according to current Canadian guideline recommendations and individual patient profiles. Structured algorithms to achieve blood pressure goals that exclude the use of a β-blocker based on the Canadian Hypertension Education Program Guidelines will be provided.
Intervention Type
Other
Intervention Name(s)
Medical Assessment
Intervention Description
medical hx, events inquiry, adherence to treatment arm periodically over 4 years
Intervention Type
Other
Intervention Name(s)
Quality of Life Assessment
Intervention Description
online questionnaires periodically over 4 years, including SAQ, EQ-5D-5L, IIEF-5 (males) or FSFI (females)
Primary Outcome Measure Information:
Title
Composite of time to first all-cause death, non-fatal MI, or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization or heart failure over an estimated four years
Description
Composite of time to first all-cause death, non-fatal MI, or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization or heart failure over an estimated four years
Time Frame
4 years post randomization
Secondary Outcome Measure Information:
Title
individual components of the primary objective (including all-cause death, non-fatal MI, or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization or HF)
Description
individual components of the primary objective (including all-cause death, non-fatal MI, or hospitalization for resuscitated cardiac arrest, unstable angina requiring urgent revascularization or HF)
Time Frame
4 years post randomization
Title
stroke
Description
stroke
Time Frame
4 years post randomization
Title
angina related quality of life
Description
angina related quality of life as measured by the Seattle Angina Questionnaire
Time Frame
4 years post randomization
Title
sexual function
Description
sexual function as measured by the IIEF-5 and FSFI
Time Frame
4 years post randomization
Title
new onset diabetes
Description
new onset diabetes
Time Frame
4 years post randomization
Title
drug withdrawal
Description
stop/re-start dates
Time Frame
4 years post randomization
Title
health care costs in each arm
Description
health care costs in each arm
Time Frame
4 years post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >21 years Documented Coronary Artery Disease (CAD) defined as: Myocardial Infarction at least 6 months prior; or Stable ischemic heart disease (defined using one of the following tests suggestive of significant coronary artery disease): i. Positive exercise stress test ii. Positive Nuclear perfusion scan iii. Positive exercise or pharmacologic echocardiographic stress test iv. Positive magnetic resonance imaging coronary perfusion scan v. Coronary computed tomographic angiography Angiogram with stenosis ≥ 70% (or left main coronary artery ≥ 50%) or significant function disease based or positive fractional flow reserve testing by CT (FFRCT); vi. Invasive coronary angiography with ≥ 70% (or left main coronary artery ≥ 50%) or significant function disease based or positive fractional flow reserve testing (FFR) or instant wave free ratio (IFR), Previous Percutaneous Coronary Intervention (PCI, at least 6 months prior if revascularization is performed for an MI); or Previous Coronary Artery Bypass Grafting (CABG, at least 6 months prior if revascularization is performed for an MI) Able and willing to provide informed consent Exclusion Criteria: Left Ventricular Ejection Fraction < 40% or current hospitalization for heart failure Myocardial infarction <6 months prior to randomization Indication for β-blocker as determined by the treating physician (such as atrial or ventricular arrhythmias or ongoing angina not controlled by another agent) Uncontrolled hypertension or uncontrolled angina symptoms (per the Investigator's discretion) Non-compliance with medical therapy Life expectancy <1 year Participation in another trial related to β-blockers or other anti-anginal drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean van Diepen, MD
Phone
587-990-5746
Email
sv9@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Kushniruk, RN, PhD
Phone
780-492-8476
Email
karin.kushniruk@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean van Diepen, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean van Diepen, MD
Phone
587-990-5746
Email
sv9@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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De-Adoption of Beta-Blockers in Patients With Stable Ischemic Heart Disease

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