Clinical trial NCT05623358: PHARM Optimal-HF Pilot
Official title: Pharmacist-led Intervention for Optimal Heart Failure Medications: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: medication
pharmacist
pharmaceutical care
pharmacotherapy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Alberta
First posted: 2022-11-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: Inclusion Criteria:

1. Provision of signed and dated informed consent form;
2. Stated willingness to comply with all study procedures and availability for the duration of the study;
3. Age ≥18 years;
4. Clinic diagnosis of HF with New York Heart Association (NYHA) functional class 1 to 3 at time of screening;
5. Left ventricular ejection fraction (LVEF) ≤40% on cardiac imaging performed within 6 months prior to enrolment;
6. Willingness to receive medications for the management of HFrEF;
7. Access to necessary resources for participating (telephone ± computer with internet access).

Exclusion Criteria:

1. Already receiving target doses of sacubitril-valsartan, evidence-based beta-blocker and a mineralocorticoid receptor antagonist at time of screening;
2. Lying/sitting systolic blood pressure \<90 mm Hg at time of enrolment;
3. Serum potassium ≥5.5 mmol/L at time of enrolment;
4. ≥2 measurements indicating estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 within 3 months prior to enrolment;
5. Being considered for heart transplant, durable mechanical circulatory support, or intravenous inotropes at time of screening;
6. Requiring diuretic dose greater than furosemide 80 mg equivalents or requiring the addition of a thiazide-like diuretic for more than 3 days at time of screening;
7. Felt by the multidisciplinary HF clinic team to be unsuitable for the trial (e.g. substance abuse and other psychological disorders, significant language barrier).

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Baseline
measure: Feasibility of achieving rapid optimal medical therapy in intervention arm
timeFrame: month 6
measure: Feasibility of patient-reported outcome measure (PROM) collection & participant retention
timeFrame: month 12
Secondary outcomes:
measure: Optimization of HFrEF medications
timeFrame: month 3
measure: Optimization of HFrEF medications
timeFrame: month 6
measure: Optimization of HFrEF medications
timeFrame: month 12
measure: Medication adherence
timeFrame: month 3
measure: Medication adherence
timeFrame: month 6
measure: Medication adherence
timeFrame: month 12
measure: Medication adverse effects
timeFrame: month 3
measure: Medication adverse effects
timeFrame: month 6
measure: Medication adverse effects
timeFrame: month 12
measure: Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: month 3
measure: Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: month 6
measure: Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: month 12
measure: Treatment burden
timeFrame: month 3
measure: Treatment burden
timeFrame: month 6
measure: Treatment burden
timeFrame: month 12
measure: Treatment satisfaction
timeFrame: month 3
measure: Treatment satisfaction
timeFrame: month 6
measure: Treatment satisfaction
timeFrame: month 12
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ricky Turgeon, BSc(Pharm), ACPR, PharmD
role: PRINCIPAL_INVESTIGATOR
References: