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Behavioural Intervention
Pharmacist-Led Medication Optimization for Heart Failure
N/A
Recruiting
Led By Ricky Turgeon, BSc(Pharm), ACPR, PharmD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Left ventricular ejection fraction (LVEF) ≤40% on cardiac imaging performed within 6 months prior to enrolment
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
Study Summary
This trial will test if a remote pharmacist-led intervention can improve medication use in people with HFrEF.
Who is the study for?
This trial is for adults over 18 with heart failure (HFrEF) and an ejection fraction of 40% or less. Participants must be able to follow the study procedures, have phone and possibly internet access, and be willing to take medications as directed. Those with severe low blood pressure, very poor kidney function, high potassium levels, or on maximum heart failure meds already are excluded.Check my eligibility
What is being tested?
The PHARM Optimal-HF Pilot compares usual care in a multidisciplinary clinic with an added pharmacist-led medication optimization via regular phone calls. The aim is to adjust heart failure medications according to guidelines over up to four months.See study design
What are the potential side effects?
While specific side effects aren't listed for this intervention since it's service-based (optimizing medication use), potential side effects may arise from changes in heart failure medications such as dizziness, low blood pressure, kidney function changes or electrolyte imbalances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart's pumping ability is reduced (LVEF ≤40%).
Select...
I am 18 years old or older.
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I have heart failure and can perform daily activities with varying degrees of difficulty.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of achieving rapid optimal medical therapy in intervention arm
Feasibility of patient-reported outcome measure (PROM) collection & participant retention
Feasibility of recruitment
Secondary outcome measures
Medication adherence
Medication adverse effects
Optimization of HFrEF medications
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Usual careExperimental Treatment1 Intervention
Both the intervention group and comparator group will receive usual care by the multidisciplinary HF clinic, including standard-of-care clinical pharmacy services.
Group II: Pharmacist-led HFrEF medication optimizationExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,416 Previous Clinical Trials
2,466,978 Total Patients Enrolled
8 Trials studying Heart Failure
5,706 Patients Enrolled for Heart Failure
University of AlbertaOTHER
889 Previous Clinical Trials
385,074 Total Patients Enrolled
25 Trials studying Heart Failure
5,573 Patients Enrolled for Heart Failure
Ricky Turgeon, BSc(Pharm), ACPR, PharmDPrincipal InvestigatorUniversity of British Columbia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function tests show a low filtration rate twice in the last 3 months.My heart's pumping ability is reduced (LVEF ≤40%).I am being considered for a heart transplant or other heart support treatments.I need more than 80 mg of water pills or an extra type for over 3 days.I am willing to take medication for heart failure with reduced ejection fraction.Your blood pressure is very low when you are sitting or lying down at the time of enrollment.I am 18 years old or older.I have heart failure and can perform daily activities with varying degrees of difficulty.I am currently on sacubitril-valsartan, a beta-blocker, and a mineralocorticoid receptor antagonist.Your blood potassium level is higher than 5.5 mmol/L when you join the study.
Research Study Groups:
This trial has the following groups:- Group 1: Pharmacist-led HFrEF medication optimization
- Group 2: Usual care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are medical professionals currently accepting participants for this trial?
"As per clinicaltrials.gov, this investigation is still looking to enrol participants. The trial was established on March 13th 2023 and amended most recently on the 9th of that same month."
Answered by AI
What is the total number of volunteers taking part in this experiment?
"Affirmative. According to clinicaltrials.gov, this research is currently recruiting patients who meet its inclusion criteria. The initial posting date was March 13th 2023 and the listing has been up-to-date as of March 9th 2023. 60 volunteers are being sought from a single trial site."
Answered by AI
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