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Behavioural Intervention

Pharmacist-Led Medication Optimization for Heart Failure

N/A

Waitlist Available

Led By Ricky Turgeon, BSc(Pharm), ACPR, PharmD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Left ventricular ejection fraction (LVEF) ≤40% on cardiac imaging performed within 6 months prior to enrolment

Age ≥18 years

Must not have

≥2 measurements indicating estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 within 3 months prior to enrolment

Being considered for heart transplant, durable mechanical circulatory support, or intravenous inotropes at time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a remote pharmacist-led intervention can improve medication use in people with HFrEF.

Who is the study for?

This trial is for adults over 18 with heart failure (HFrEF) and an ejection fraction of 40% or less. Participants must be able to follow the study procedures, have phone and possibly internet access, and be willing to take medications as directed. Those with severe low blood pressure, very poor kidney function, high potassium levels, or on maximum heart failure meds already are excluded.

What is being tested?

The PHARM Optimal-HF Pilot compares usual care in a multidisciplinary clinic with an added pharmacist-led medication optimization via regular phone calls. The aim is to adjust heart failure medications according to guidelines over up to four months.

What are the potential side effects?

While specific side effects aren't listed for this intervention since it's service-based (optimizing medication use), potential side effects may arise from changes in heart failure medications such as dizziness, low blood pressure, kidney function changes or electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's pumping ability is reduced (LVEF ≤40%).

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I am 18 years old or older.

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I have heart failure and can perform daily activities with varying degrees of difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function tests show a low filtration rate twice in the last 3 months.

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I am being considered for a heart transplant or other heart support treatments.

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I need more than 80 mg of water pills or an extra type for over 3 days.

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I am currently on sacubitril-valsartan, a beta-blocker, and a mineralocorticoid receptor antagonist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of achieving rapid optimal medical therapy in intervention arm

Feasibility of patient-reported outcome measure (PROM) collection & participant retention

Feasibility of recruitment

Secondary study objectives

Medication adherence

Medication adverse effects

Optimization of HFrEF medications

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual careExperimental Treatment1 Intervention

Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.

Group II: Pharmacist-led HFrEF medication optimizationExperimental Treatment2 Interventions

0 / 7Eligibility criteria met