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

Coronary Artery Disease Clinical Trial

— ABBREVIATE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05081999
• Other study ID #: Pro00113192
• Status: Recruiting
• Phase: Phase 4
• Start date: January 30, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: University of Alberta
• Contact: Sean van Diepen, MD
• Phone: 587-990-5746
• Email: sv9[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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 ß-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 ß-blockers or other anti-anginal drugs

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia
• Stable Ischemic Heart Disease

Intervention

Other:
• Medical Assessment
medical hx, events inquiry, adherence to treatment arm periodically over 4 years
• Quality of Life Assessment
online questionnaires periodically over 4 years, including SAQ, EQ-5D-5L, IIEF-5 (males) or FSFI (females)

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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
Secondary	stroke	stroke	4 years post randomization
Secondary	angina related quality of life	angina related quality of life as measured by the Seattle Angina Questionnaire	4 years post randomization
Secondary	sexual function	sexual function as measured by the IIEF-5 and FSFI	4 years post randomization
Secondary	new onset diabetes	new onset diabetes	4 years post randomization
Secondary	drug withdrawal	stop/re-start dates	4 years post randomization
Secondary	health care costs in each arm	health care costs in each arm	4 years post randomization