PHARM Optimal-HF Pilot

NCT05623358 | Active Not Recruiting

• 1 other identifier: H21-01774
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

medication; pharmacist; pharmaceutical care; pharmacotherapy

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline

• 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

  month 6

• 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

  month 12

Secondary Outcomes (18)

• Optimization of HFrEF medications

  month 3

• Optimization of HFrEF medications

  month 6

• Optimization of HFrEF medications

  month 12

• Medication adherence

  month 3

• Medication adherence

  month 6

Study Arms (2)

Pharmacist-led HFrEF medication optimization

EXPERIMENTAL

Other: Pharmacist-led HFrEF medication optimization; Other: Usual care

Usual care

OTHER

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

Other: Usual care

Interventions

Pharmacist-led HFrEF medication optimization OTHER

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.

Pharmacist-led HFrEF medication optimization

Usual care OTHER

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.

Pharmacist-led HFrEF medication optimization; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form;
• Stated willingness to comply with all study procedures and availability for the duration of the study;
• Age ≥18 years;
• Clinic diagnosis of HF with New York Heart Association (NYHA) functional class 1 to 3 at time of screening;
• Left ventricular ejection fraction (LVEF) ≤40% on cardiac imaging performed within 6 months prior to enrolment;
• Willingness to receive medications for the management of HFrEF;
• Access to necessary resources for participating (telephone ± computer with internet access).

You may not qualify if:

• Already receiving target doses of sacubitril-valsartan, evidence-based beta-blocker and a mineralocorticoid receptor antagonist at time of screening;
• Lying/sitting systolic blood pressure \<90 mm Hg at time of enrolment;
• Serum potassium ≥5.5 mmol/L at time of enrolment;
• ≥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;
• 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;
• Felt by the multidisciplinary HF clinic team to be unsuitable for the trial (e.g. substance abuse and other psychological disorders, significant language barrier).

Sponsors & Collaborators

• University of British Columbia: lead
• University of Alberta: collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Study Officials

• Ricky Turgeon, BSc(Pharm), ACPR, PharmD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 21, 2022
• Study Start: March 13, 2023
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)