PHARM Optimal-HF Pilot

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Pharmacist-led Intervention for Optimal Heart Failure Medications: A Pilot Randomized Controlled Trial

Conditions

Heart Failure With Reduced Ejection Fraction

Being tested

Pharmacist-led HFrEF medication optimization, Usual care

Keywords

medication, pharmacist, pharmaceutical care, pharmacotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Pharmacist-led HFrEF medication optimizationOther

  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.

• Usual careOther

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Baseline

2. 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

   Measured: month 6

3. 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

   Measured: month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted21 Nov 2022
2. Study start13 Mar 2023
3. Primary completion1 Jun 2025 (estimated)
4. Study completion1 Sep 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
• More trials run by University of British ColumbiaThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.