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NCT Number: NCT05081999

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Stable Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Beta-blocker Therapy Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Assessment

Other

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

Quality of Life Assessment

Other

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

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

    Time frame: 4 years post randomization

    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 outcomes

  1. 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

    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)

  2. stroke

    Time frame: 4 years post randomization

    stroke

  3. angina related quality of life

    Time frame: 4 years post randomization

    angina related quality of life as measured by the Seattle Angina Questionnaire

  4. sexual function

    Time frame: 4 years post randomization

    sexual function as measured by the IIEF-5 and FSFI

  5. new onset diabetes

    Time frame: 4 years post randomization

    new onset diabetes

  6. drug withdrawal

    Time frame: 4 years post randomization

    stop/re-start dates

  7. health care costs in each arm

    Time frame: 4 years post randomization

    health care costs in each arm

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study 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

Acronym: ABBREVIATE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2021
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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