PHARM Optimal-HF Pilot

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623358
• Other study ID #: H21-01774
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: University of British Columbia
• Contact: Ricky Turgeon, BSc(Pharm), ACPR, PharmD
• Phone: 2367776961
• Email: ricky.turgeon[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	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.	Baseline
Primary	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
Primary	Feasibility of patient-reported outcome measure (PROM) collection & participant retention	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	month 12
Secondary	Optimization of HFrEF medications	Modified optimal medical therapy (OMT) score. Range 0 (worst) to 8 (best): suboptimal (0-4), acceptable (5-7), optimal (8).	month 3
Secondary	Optimization of HFrEF medications	Modified optimal medical therapy (OMT) score	month 6
Secondary	Optimization of HFrEF medications	Modified optimal medical therapy (OMT) score	month 12
Secondary	Medication adherence	5-item Medication Adherence Report Scale (MARS-5)	month 3
Secondary	Medication adherence	5-item Medication Adherence Report Scale (MARS-5)	month 6
Secondary	Medication adherence	5-item Medication Adherence Report Scale (MARS-5)	month 12
Secondary	Medication adverse effects	Open-ended question about HF medications	month 3
Secondary	Medication adverse effects	Open-ended question about HF medications	month 6
Secondary	Medication adverse effects	Open-ended question about HF medications	month 12
Secondary	Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)		month 3
Secondary	Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)		month 6
Secondary	Quality of life: 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12)		month 12
Secondary	Treatment burden	Treatment Burden Questionnaire (TBQ)	month 3
Secondary	Treatment burden	Treatment Burden Questionnaire (TBQ)	month 6
Secondary	Treatment burden	Treatment Burden Questionnaire (TBQ)	month 12
Secondary	Treatment satisfaction	Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)	month 3
Secondary	Treatment satisfaction	Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)	month 6
Secondary	Treatment satisfaction	Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)	month 12