Pharmacist-Led Medication Optimization for Heart Failure

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

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Low blood pressure, High potassium, Low eGFR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 16 weeks

42 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, the study involves adjusting medications to optimize treatment for heart failure, so changes to your medication regimen may occur.

What data supports the effectiveness of the treatment Pharmacist-led HFrEF medication optimization?

Research shows that pharmacist-led care in heart failure management can improve medication use and outcomes, such as increasing the use of important heart medications like beta blockers and reducing the use of less preferred drugs. ^{1 2 3 4 5}

Is pharmacist-led medication optimization for heart failure safe?

Pharmacist-led medication optimization for heart failure appears to be safe, as studies show no significant differences in hospital mortality rates or adverse drug reactions when pharmacists are involved in medication management. ^{1 2 6 7 8}

How is pharmacist-led HFrEF medication optimization different from other heart failure treatments?

This treatment is unique because it involves pharmacists actively participating in the healthcare team to optimize heart failure medications, ensuring patients receive the most effective drugs like beta blockers and reducing the use of non-preferred medications. This approach has shown to improve medication adherence and outcomes compared to standard care without pharmacist involvement. ^{2 4 5 6 9}

Research Team

Ricky Turgeon, BSc(Pharm), ACPR, PharmD

Principal Investigator

University of British Columbia

Eligibility Criteria

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.

Inclusion Criteria

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

Access to necessary resources for participating (telephone ± computer with internet access)

Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Felt by the multidisciplinary HF clinic team to be unsuitable for the trial (e.g. substance abuse and other psychological disorders, significant language barrier)

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive co-management of medications by a dedicated study pharmacist with remote encounters every 1-2 weeks for up to 4 months

16 weeks

8-16 visits (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up assessments at 6 and 12 months

12 months

2 visits (remote or in-person)

Treatment Details

Interventions

• Pharmacist-led HFrEF medication optimization
• Usual care

Trial Overview 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.

Participant Groups

Group I: Usual care Experimental Treatment 1 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 optimization Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Findings from Research

In a study of 110 patients with heart failure and reduced ejection fraction (HFrEF), the inclusion of clinical pharmacists in the healthcare team significantly increased the percentage of patients reaching target doses of key medications, such as ACE inhibitors and beta blockers, from 0% to 77.4% and from 8.6% to 66.1%, respectively.

The up-titration of these medications led to notable improvements in clinical outcomes, including better ejection fraction and enhanced scores on the New York Heart Association (NYHA) scale, demonstrating the effectiveness of pharmacist interventions in managing heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Pharmacist's Intervention to Improve Medication Titration for Heart Failure: First Experience from Sudan. Ahmed, KO., Taj Eldin, I., Yousif, M., et al.[2022]

Pharmacist care significantly improves medication adherence, patient knowledge, and quality of life in outpatients with heart failure, based on a systematic review of 24 randomized controlled trials involving 8029 patients.

While pharmacist interventions did not show statistically significant reductions in all-cause mortality or hospitalizations, they did enhance symptom control and overall quality of life, suggesting that pharmacists play a crucial role in managing complex medication regimens for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence for pharmacist care in outpatients with heart failure: a systematic review and meta-analysis. Schumacher, PM., Becker, N., Tsuyuki, RT., et al.[2021]

In a study involving 2,164 patients with left ventricular systolic dysfunction, a pharmacist-led intervention improved the prescribing of heart failure medications, with significant increases in treatment initiation and dose adjustments compared to usual care.

Despite these improvements in medication management, the intervention did not lead to better clinical outcomes, such as reduced death or hospital admissions for heart failure, indicating that the baseline treatment levels were already high among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. Lowrie, R., Mair, FS., Greenlaw, N., et al.[2022]

This study is designed to evaluate the impact of pharmacist-led interventions on mortality and hospitalization rates in patients with systolic heart failure, involving 2,169 patients across 174 practices over a mean follow-up of 5 years.

The trial aims to provide strong evidence on whether optimizing pharmacological therapy through pharmacists can improve patient outcomes, with over 750 expected primary outcome events (deaths or hospitalizations) during the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Heart failure and Optimal Outcomes from Pharmacy Study (HOOPS): rationale, design, and baseline characteristics. Lowrie, R., Mair, FS., Greenlaw, N., et al.[2012]

Pharmacist medication reviews significantly reduced drug-related problems (DRPs) in patients with heart failure, decreasing the average DRPs per patient from 2.80 to 1.95 after intervention, based on a study of 128 patients (64 control and 64 intervention).

The intervention not only improved the overall management of medications but also showed high acceptance rates for critical areas such as medication adherence (78%) and renal dosing (67%), indicating the effectiveness of pharmacists in enhancing patient care in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Pharmacist Medication Review Service in an Outpatient Heart Failure Clinic. Yates, L., Valente, M., Wadsworth, C.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Pharmacist's Intervention to Improve Medication Titration for Heart Failure: First Experience from Sudan. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Pharmacist-led intervention in the multidisciplinary team approach optimizes heart failure medication. [2018]

3. England pubmed.ncbi.nlm.nih.gov

The evidence for pharmacist care in outpatients with heart failure: a systematic review and meta-analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Outcome Benefits Seen With 1 Year of Optimized Sacubitril/Valsartan for the Treatment of Systolic Heart Failure Managed by Pharmacists in a Cardiology Practice. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacist intervention in primary care to improve outcomes in patients with left ventricular systolic dysfunction. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The Heart failure and Optimal Outcomes from Pharmacy Study (HOOPS): rationale, design, and baseline characteristics. [2012]

7. England pubmed.ncbi.nlm.nih.gov

Are patients in heart failure trials representative of primary care populations? A systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Pharmacist Medication Review Service in an Outpatient Heart Failure Clinic. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Pharmacist-Driven Aldosterone Antagonist Stewardship Program in Patients With Heart Failure. [2022]