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

Last updated: February 3, 2025
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

4

Condition

Coronary Artery Disease

Chest Pain

Hypercholesterolemia

Treatment

Medical Assessment

Quality of Life Assessment

Clinical Study ID

NCT05081999
Pro00113192
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

  • Previous Percutaneous Coronary Intervention (PCI, at least 6 months prior ifrevascularization is performed for an MI); or

  • Previous Coronary Artery Bypass Grafting (CABG, at least 6 months prior ifrevascularization is performed for an MI)

  1. Able and willing to provide informed consent

Exclusion

Exclusion Criteria:

  1. Left Ventricular Ejection Fraction < 40% or current hospitalization for heartfailure

  2. Myocardial infarction <6 months prior to randomization

  3. Indication for β-blocker as determined by the treating physician (such as atrial orventricular arrhythmias or ongoing angina not controlled by another agent)

  4. Uncontrolled hypertension or uncontrolled angina symptoms (per the Investigator'sdiscretion)

  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

Study Design

Total Participants: 8500
Treatment Group(s): 2
Primary Treatment: Medical Assessment
Phase: 4
Study Start date:
January 30, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

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