Trial Summary
What is the purpose of this trial?The goal if this pilot randomized controlled trial is to determine the feasibility of conducting and guide the design of a definitive trial of a pharmacist-led, remotely-administered intervention to optimize medications for heart failure (HF) with reduced ejection fraction (HFrEF) as part of a multidisciplinary HF clinic.
Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.
In addition to usual care, participants randomized to the intervention arm will receive co-management of medications by a dedicated study pharmacist with advanced training and expanded scope of practice, with the aim of achieving optimal medical therapy for HFrEF based on the 2021 Canadian Cardiovascular Society HF guidelines. The intervention will consist of 30-minute remote (telephone) encounters with a clinical pharmacist every 1-2 weeks with the aim of initiating or titrating ≥1 medication per encounter using standard protocols, for an intervention duration of up to 4 months.
Eligibility Criteria
This trial is for adults over 18 with heart failure (HFrEF) and an ejection fraction of 40% or less. Participants must be able to follow the study procedures, have phone and possibly internet access, and be willing to take medications as directed. Those with severe low blood pressure, very poor kidney function, high potassium levels, or on maximum heart failure meds already are excluded.Inclusion Criteria
My heart's pumping ability is reduced (LVEF ≤40%).
Access to necessary resources for participating (telephone ± computer with internet access)
Stated willingness to comply with all study procedures and availability for the duration of the study
+4 more
Exclusion Criteria
Felt by the multidisciplinary HF clinic team to be unsuitable for the trial (e.g. substance abuse and other psychological disorders, significant language barrier)
My kidney function tests show a low filtration rate twice in the last 3 months.
I am being considered for a heart transplant or other heart support treatments.
+4 more
Participant Groups
The PHARM Optimal-HF Pilot compares usual care in a multidisciplinary clinic with an added pharmacist-led medication optimization via regular phone calls. The aim is to adjust heart failure medications according to guidelines over up to four months.
2Treatment groups
Experimental Treatment
Group I: Usual careExperimental Treatment1 Intervention
Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.
Group II: Pharmacist-led HFrEF medication optimizationExperimental Treatment2 Interventions
Find a Clinic Near You
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
University of AlbertaCollaborator