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Active Not RecruitingNCT05081999

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

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

Status
Active Not Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
59 (actual)
Sponsor
University of Alberta · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMedical Assessmentmedical hx, events inquiry, adherence to treatment arm periodically over 4 years
OTHERQuality of Life Assessmentonline questionnaires periodically over 4 years, including SAQ, EQ-5D-5L, IIEF-5 (males) or FSFI (females)

Timeline

Start date
2023-01-30
Primary completion
2026-01-31
Completion
2026-12-31
First posted
2021-10-18
Last updated
2026-03-16

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05081999. Inclusion in this directory is not an endorsement.