PHARM Optimal-HF Pilot

Pharmacist-led Intervention for Optimal Heart Failure Medications: A Pilot Randomized Controlled 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.

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).