PHARM Optimal-HF Pilot

Not Applicable

Active, not recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Other: Pharmacist-led HFrEF medication optimization; Other: Usual care

• Registration Number: NCT05623358
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-21
• Study Start: 2023-03-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist-led HFrEF medication optimization	Pharmacist-led HFrEF medication optimization	-
Pharmacist-led HFrEF medication optimization	Usual care	-
Usual care	Usual care	Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment	Baseline	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.
Feasibility of achieving rapid optimal medical therapy in intervention arm	month 6	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
Feasibility of patient-reported outcome measure (PROM) collection & participant retention	month 12	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

Secondary Outcome Measures

Name	Time	Method
Treatment burden	month 12	Treatment Burden Questionnaire (TBQ)
Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	month 12
Treatment satisfaction	month 12	Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Medication adverse effects	month 12	Open-ended question about HF medications
Optimization of HFrEF medications	month 12	Modified optimal medical therapy (OMT) score
Medication adherence	month 12	5-item Medication Adherence Report Scale (MARS-5)

Trial Locations

Locations (1)

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada