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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pharmacists can optimize medications for individuals with heart failure and a reduced ejection fraction (a measure of heart pumping efficiency). The researchers aim to determine if remote medication management by a pharmacist can enhance care. Participants will either continue their usual care or receive additional support from a pharmacist, who will adjust their medications every couple of weeks over the phone. This trial suits individuals with heart failure who have a left ventricular ejection fraction of 40% or less and are open to changing their medications. As an unphased trial, it offers participants the chance to contribute to innovative approaches in heart failure care.

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 prior data suggests that this pharmacist-led medication optimization is safe for heart failure patients?

Research has shown that pharmacist involvement in adjusting heart failure medications is generally safe and well-tolerated. Studies have found that this approach can reduce hospital visits for heart failure patients. Specifically, one study discovered that patients whose medications pharmacists adjusted had fewer hospital stays for any reason within 30 days compared to those without such assistance.

Moreover, pharmacists have successfully helped patients adhere to heart failure treatment guidelines over time. This indicates that the approach is both effective and manageable for patients. While ongoing studies aim to further explore this method, current evidence supports its safety and effectiveness in improving heart failure treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharmacist-led medication optimization for heart failure with reduced ejection fraction (HFrEF) because it offers a personalized approach to managing medications. Unlike the standard of care, which often involves a one-size-fits-all strategy, this method leverages the expertise of pharmacists to tailor medication plans specifically for each individual. This can potentially improve medication adherence and optimize therapeutic outcomes by closely monitoring and adjusting treatments based on the patient's unique response. This personalized care approach could lead to better management of heart failure symptoms and overall patient health.

What evidence suggests that pharmacist-led medication optimization is effective for heart failure?

Research has shown that involving pharmacists in the care of heart failure patients can be very beneficial. Specifically, for patients with reduced ejection fraction, pharmacists help ensure that medications align with medical guidelines. This trial will compare two approaches: one group will receive pharmacist-led medication optimization, potentially leading to quicker and more effective medication adjustments, while the other group will receive usual care. Patients receiving focused attention from pharmacists may experience a better quality of life and adhere to their medication plans more easily. ^{3 5 6 7 8}

Who Is on the Research Team?

Ricky Turgeon, BSc(Pharm), ACPR, PharmD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

Citations

1. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1920

Evaluation of PHARM‐HF, a pharmacist‐led heart failure ... Prospective, randomized studies are underway to evaluate the impact of pharmacist-led medication optimization on clinical outcomes in HFrEF.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12140189/

Pharmacist-led rapid uptitration clinic in heart failure ... The study assessed clinical outcomes of 86 patients at baseline, following discharge from the virtual ward (typically after 4 weeks), and at 3–6 ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06450522

Study Details | NCT06450522 | Post-Discharge Pharmacist ... Outcome data will include information from patients on quality of life, treatment burden, medication adherence, as well as information from their medical record ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949969025000314

Outcomes of a hybrid heart failure clinic model on ... Our study findings add to the evidence base that pharmacist involvement in heart failure clinics improves GDMT optimization.

5. pharmacist.com pharmacist.com/Blogs/CEO-Blog/pharmacist-led-hf-clinic-optimizes-therapy-and-improves-outcomes

Pharmacist-led HF clinic optimizes therapy and improves ... The study, called PHARM-HF, was a retrospective, pre–post study that evaluated chart reviews of 81 patients from January 2021 to August 2022.

6. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1450

Pharmacist‐led optimization of heart failure medications: A ... All-cause hospitalizations at 30 days were significantly lower in one study with pharmacist-led medication optimization compared with a control ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12406906/

Pharmacist-led guideline-directed medical therapy in heart ... Secondary outcomes. Pharmacists covered the greatest proportions of HF GDMT at 6 months (36.6%) and 2 years (42.1%) compared with nurses (32.9% ...

8. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.16261

Abstract 16261: Pharmacy-Led Optimization of Guideline- ... Research Question: Does a safety-net pharmacy-led program lead to significant change in medication rates, all-cause/HF admissions, and HF ...