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

NCT05081999 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: Pro00113192
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  4 years post randomization

Secondary Outcomes (7)

• 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)

  4 years post randomization

• stroke

  4 years post randomization

• angina related quality of life

  4 years post randomization

• sexual function

  4 years post randomization

• new onset diabetes

  4 years post randomization

Study Arms (2)

Continuation of Beta-Blockers

OTHER

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).

Other: Medical Assessment; Other: Quality of Life Assessment

De-Adoption of Beta-Blockers

OTHER

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.

Other: Medical Assessment; Other: Quality of Life Assessment

Interventions

Medical Assessment OTHER

medical hx, events inquiry, adherence to treatment arm periodically over 4 years

Continuation of Beta-Blockers; De-Adoption of Beta-Blockers

Quality of Life Assessment OTHER

online questionnaires periodically over 4 years, including SAQ, EQ-5D-5L, IIEF-5 (males) or FSFI (females)

Continuation of Beta-Blockers; De-Adoption of Beta-Blockers

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Independent Medical Evaluation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Sean van Diepen, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 18, 2021
• Study Start: January 30, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)