St. Paul's Hospital
Vancouver, British Columbia, Canada
NCT Number: NCT05623358
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Vancouver, British Columbia, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
Composite of:
Time frame: month 6
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 12
Composite of:
Time frame: month 3
Modified optimal medical therapy (OMT) score. Range 0 (worst) to 8 (best): suboptimal (0-4), acceptable (5-7), optimal (8).
Time frame: month 6
Modified optimal medical therapy (OMT) score
Time frame: month 12
Modified optimal medical therapy (OMT) score
Time frame: month 3
5-item Medication Adherence Report Scale (MARS-5)
Time frame: month 6
5-item Medication Adherence Report Scale (MARS-5)
Time frame: month 12
5-item Medication Adherence Report Scale (MARS-5)
Time frame: month 3
Open-ended question about HF medications
Time frame: month 6
Open-ended question about HF medications
Time frame: month 12
Open-ended question about HF medications
Time frame: month 3
Time frame: month 6
Time frame: month 12
Time frame: month 3
Treatment Burden Questionnaire (TBQ)
Time frame: month 6
Treatment Burden Questionnaire (TBQ)
Time frame: month 12
Treatment Burden Questionnaire (TBQ)
Time frame: month 3
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Time frame: month 6
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Time frame: month 12
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
University of British Columbia
Other
Pharmacist-led Intervention for Optimal Heart Failure Medications: A Pilot Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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