Evaluating the effects of stopping beta-blockers in heart disease patients
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
This study tests if stopping beta-blockers helps people with stable heart disease feel better and stay healthier compared to those who keep taking them.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 8500 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05081999 on ClinicalTrials.gov |
What this trial studies
This study investigates whether patients with stable ischemic heart disease should continue or discontinue beta-blocker therapy. Participants will be randomly assigned to either continue or stop taking beta-blockers, and their health outcomes will be monitored remotely over four years. The study will assess cardiovascular events and quality of life through web-based questionnaires to determine the impact of these medications on patient well-being and health outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 with documented coronary artery disease or stable ischemic heart disease.
Not a fit: Patients without a history of coronary artery disease or those who are not currently on beta-blocker therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help clarify the role of beta-blockers in heart disease treatment, potentially improving patient care and medication management.
How similar studies have performed: Other studies have explored the role of beta-blockers in heart disease, but this specific approach to de-adoption is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Sean van Diepen, MD — University of Alberta
- Study coordinator: Sean van Diepen, MD
- Email: sv9@ualberta.ca
- Phone: 587-990-5746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.