Clinical trial NCT05081999: De-Adoption of Beta-Blockers in Patients With Stable Ischemic Heart Disease
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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Stable Ischemic Heart Disease
Coronary Artery Disease
Beta-blocker Therapy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 8500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 4 years post randomization
Secondary outcomes:
measure: 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)
timeFrame: 4 years post randomization
measure: stroke
timeFrame: 4 years post randomization
measure: angina related quality of life
timeFrame: 4 years post randomization
measure: sexual function
timeFrame: 4 years post randomization
measure: new onset diabetes
timeFrame: 4 years post randomization
measure: drug withdrawal
timeFrame: 4 years post randomization
measure: health care costs in each arm
timeFrame: 4 years post randomization
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sean van Diepen, MD
role: PRINCIPAL_INVESTIGATOR
References: