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Active, Not Recruiting

NCT Number: NCT05623358

PHARM Optimal-HF Pilot

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Feasibility of recruitment

    Time frame: Baseline

    Composite of:

    • Proportion eligible at pre-screening ≥50% of all HF clinic patients assessed based on inclusion criteria at pre-screening;
    • Proportion eligible at screening ≥25% of all patients based on inclusion and exclusion criteria on screening;
    • Mean recruitment ≥2 participants/week.
  2. Feasibility of achieving rapid optimal medical therapy in intervention arm

    Time frame: 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

  3. Feasibility of patient-reported outcome measure (PROM) collection & participant retention

    Time frame: month 12

    Composite of:

    • Follow-up at 6 months complete in ≥90% at 6 months, ≥80% at 12 months, excluding deaths
    • ≥90% completion of PROM questionnaires at months 3 and 6, and ≥80% completion at month 12

Secondary outcomes

  1. Optimization of HFrEF medications

    Time frame: month 3

    Modified optimal medical therapy (OMT) score. Range 0 (worst) to 8 (best): suboptimal (0-4), acceptable (5-7), optimal (8).

  2. Optimization of HFrEF medications

    Time frame: month 6

    Modified optimal medical therapy (OMT) score

  3. Optimization of HFrEF medications

    Time frame: month 12

    Modified optimal medical therapy (OMT) score

  4. Medication adherence

    Time frame: month 3

    5-item Medication Adherence Report Scale (MARS-5)

  5. Medication adherence

    Time frame: month 6

    5-item Medication Adherence Report Scale (MARS-5)

  6. Medication adherence

    Time frame: month 12

    5-item Medication Adherence Report Scale (MARS-5)

  7. Medication adverse effects

    Time frame: month 3

    Open-ended question about HF medications

  8. Medication adverse effects

    Time frame: month 6

    Open-ended question about HF medications

  9. Medication adverse effects

    Time frame: month 12

    Open-ended question about HF medications

  10. Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Time frame: month 3

  11. Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Time frame: month 6

  12. Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Time frame: month 12

  13. Treatment burden

    Time frame: month 3

    Treatment Burden Questionnaire (TBQ)

  14. Treatment burden

    Time frame: month 6

    Treatment Burden Questionnaire (TBQ)

  15. Treatment burden

    Time frame: month 12

    Treatment Burden Questionnaire (TBQ)

  16. Treatment satisfaction

    Time frame: month 3

    Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)

  17. Treatment satisfaction

    Time frame: month 6

    Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)

  18. Treatment satisfaction

    Time frame: month 12

    Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • University of Alberta

Registry information

Official study title

Pharmacist-led Intervention for Optimal Heart Failure Medications: A Pilot Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2022
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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