PHARM Optimal-HF Pilot

NCT ID: NCT05623358

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2025-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pharmacist-led HFrEF medication optimization

Group Type: EXPERIMENTAL

Pharmacist-led HFrEF medication optimization

Intervention Type: 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.

Usual care

Intervention Type: 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.

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.

Group Type: OTHER

Usual care

Intervention Type: 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.

Interventions

Pharmacist-led HFrEF medication optimization

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.

Intervention Type: OTHER

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. 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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ricky Turgeon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricky Turgeon, BSc(Pharm), ACPR, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

St. Paul's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H21-01774

Identifier Type: -

Identifier Source: org_study_id