An interventional study of Pharmacist-led HFrEF medication optimization and Usual care in Heart Failure With Reduced Ejection Fraction, sponsored by University of British Columbia. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by University of British Columbia · Not applicable, Interventional, and Health services research
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 42 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Pharmacist-led HFrEF medication optimization · Other: Usual care
Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.
Other: Usual care
In addition to usual care, participants randomized to the intervention arm will receive co-management of medications by a clinical pharmacist with advanced training and expanded scope of practice, with the aim of achieving optimal medical therapy (OMT) for HFrEF as outlined by the 2021 Canadian Cardiovascular Society (CCS) HF guidelines. This will consist of, where possible, the combination of an angiotensin receptor-neprilysin inhibitor (ARNI), evidence-based beta-blocker, mineralocorticoid receptor antagonist (MRA), and sodium-glucose cotransporter 2 inhibitor (SGLT2i) at target doses, along with personalized therapies as outlined in the 2021 CCS HF guidelines, unless the patient is unable to tolerate these agents/doses.
Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services. The standard pathway in the HF clinic consists of an initial consultation with the multidisciplinary team (cardiologist, physician trainees, registered nurse and clinical pharmacist), follow-up visits approximately every 3 months with the nurse and cardiologist until discharge, along with telehealth nurse calls for medication titrations.
Feasibility of recruitment
Composite of: 1. Proportion eligible at pre-screening ≥50% of all HF clinic patients assessed based on inclusion criteria at pre-screening; 2. Proportion eligible at screening ≥25% of all patients based on inclusion and exclusion criteria on screening; 3. Mean recruitment ≥2 participants/week.
Time frame: Baseline
Feasibility of achieving rapid optimal medical therapy in intervention arm
Feasibility of optimizing HFrEF pharmacotherapy with study intervention, defined as ≥90% attainment of modified OMT score \[acceptable\] ≥5 at 3 months in intervention arm and ≥80% attainment of modified OMT score 8 \[optimal\] at 6 months in intervention arm
Time frame: month 6
Feasibility of patient-reported outcome measure (PROM) collection & participant retention
Composite of: 1. Follow-up at 6 months complete in ≥90% at 6 months, ≥80% at 12 months, excluding deaths 2. ≥90% completion of PROM questionnaires at months 3 and 6, and ≥80% completion at month 12
Time frame: month 12
Optimization of HFrEF medications
Modified optimal medical therapy (OMT) score. Range 0 (worst) to 8 (best): suboptimal (0-4), acceptable (5-7), optimal (8).
Time frame: month 3
Optimization of HFrEF medications
Modified optimal medical therapy (OMT) score
Time frame: month 6
Optimization of HFrEF medications
Modified optimal medical therapy (OMT) score
Time frame: month 12
Medication adherence
5-item Medication Adherence Report Scale (MARS-5)
Time frame: month 3
Medication adherence
5-item Medication Adherence Report Scale (MARS-5)
Time frame: month 6
Medication adherence
5-item Medication Adherence Report Scale (MARS-5)
Time frame: month 12
Medication adverse effects
Open-ended question about HF medications
Time frame: month 3
Medication adverse effects
Open-ended question about HF medications
Time frame: month 6
Medication adverse effects
Open-ended question about HF medications
Time frame: month 12
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: month 3
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: month 6
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: month 12
Treatment burden
Treatment Burden Questionnaire (TBQ)
Time frame: month 3
Treatment burden
Treatment Burden Questionnaire (TBQ)
Time frame: month 6
Treatment burden
Treatment Burden Questionnaire (TBQ)
Time frame: month 12
Treatment satisfaction
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Time frame: month 3
Treatment satisfaction
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Time frame: month 6
Treatment satisfaction
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Time frame: month 12
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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University of British Columbia