Heart Failure with Reduced Ejection Fraction HFrEFNCT06450522
Post-Discharge Pharmacist-led Rapid Medication Optimization for Heart Failure (Post-Discharge PHARM-HF)
A study testing Pharmacist co-management of HF medication optimization in people with Heart Failure with Reduced Ejection Fraction HFrEF, run by University of British Columbia at 1 site in Canada.
Trial summary
This study will recruit 100 patients from a post-discharge medicine clinic to test if the addition of a pharmacist to manage heart failure medications can increase appropriate use of these medications. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure with Reduced Ejection Fraction HFrEF
- What is being tested?
- Pharmacist co-management of HF medication optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2024to 21 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥19 years;
- Attending their initial visit to the PDMC;
- Diagnosis of HF.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Discharge Pharmacist-led Rapid Medication Optimization for Heart Failure (Post-Discharge PHARM-HF): a Randomized Controlled Trial
This study will recruit 100 patients from a post-discharge medicine clinic to test if the addition of a pharmacist to manage heart failure medications can increase appropriate use of these medications. Participants will be randomly assigned to usual care alone or with the addition of a pharmacist to help manage medications. They will be followed for 3 months by telephone/electronically-administered questionnaires, and 12 months using administrative health records. Outcome data will include information from patients on quality of life, treatment burden, medication adherence, as well as information from their medical record on heart failure events.
- Being tested
- Pharmacist co-management of HF medication optimization, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist co-management of HF medication optimizationOther
In addition to usual care, participants with an initial Post-Discharge Medicine Clinic visit randomized to the intervention arm will receive pharmacist co-management of their medications, with the intent of to achieve rapid, maximum-tolerated pharmacotherapy for HFrEF as outlined by the 2021 CCS HF guidelines, and for HFmrEF/HFpEF as outlined by the 2022 ACC/AHA HF guidelines. This intervention will be delivered by a staff pharmacist at the St. Paul's Hospital, using the standard procedures outlined below:
For HFrEF: Where possible, a patient will be prescribed the combination of an ARNI, evidence-based beta-blocker, MRA, and SGLT2i at target HFrEF doses, along with personalized therapies as outlined in the 2021 CCS HF guidelines.
For HFmrEF: We will target ACEI/ARB/ARNI+BB+MRA+SGLT2i. For HFpEF: We will target SGLT2i+MRA +/- ACEI/ARB/ARNI. The intervention will incorporate key components identified in a systematic review of observational studies of pharmacist-led optimization of HF.
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist co-management | Experimental | In addition to usual care, participants with an initial Post-Discharge Medicine Clinic visit randomized to the intervention arm will receive pharmacist co-management of their medications, with the intent of to achieve rapid, maximum-tolerated pharmacotherapy for HF as outlined in the latest guidelines. This intervention will be delivered by a staff pharmacist at the St. Paul's Hospital, using the standard procedures outlined below:
For HFrEF, where possible, a patient will be prescribed the combination of an ARNI, evidence-based beta-blocker, MRA, and SGLT2i at target HFrEF doses, along with personalized therapies as outlined in the 2021 CCS HF guidelines.
For HFmrEF, we will target ACEI/ARB/ARNI, beta-blocker, MRA, and SGLT2i. For HFpEF, we will target SGLT2i + MRA +/- ACEI/ARB/ARNI. The intervention will incorporate key components identified in a systematic review of observational studies of pharmacist-led optimization of HF. Receives: Other: Pharmacist co-management of HF medication optimization |
| Usual care | Other | Usual care: Both the intervention group and comparator group will receive usual care by the Post-Discharge Medicine Clinic, which does not include clinical pharmacy services. The standard pathway in the St. Paul's Hospital Post-Discharge Medicine Clinic consists of an initial consultation with the clinic internist within 2 weeks of discharge, followed by two visits approximately 1 week apart with the Post-Discharge Medicine Clinic internist, followed by discharge from the clinic. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimization Potential Score
Score that quantifies guideline-directed medical therapy (GDMT) use in heart failure with reduced ejection fraction. The score ranges from 0 (worst) to 10 (best).
For HFmrEF, this will be modified to assign equal weight to ACEI/ARB/ARNI (score range 0-8).
For HFpEF, this will be further modified to assign equal weight to ACEI/ARB/ARNI, and to assign no points for beta-blocker use (score range 0-6).
Measured: 3 months
Secondary outcomes (1)
Composite hierarchical outcome
Hierarchical composite outcome of time to all-cause death, time to first all-cause hospitalization, the number of HF events (including HF hospitalizations or emergency department visits for HF), ≥5-point Kansas City Cardiomyopathy Questionnaire-12 summary score improvement, or ≥2-point OPS increase
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start4 Jul 2024
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure with Reduced Ejection Fraction HFrEFStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricky Turgeon, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450522
- Sponsor's protocol ID
- H24-00300
- Status last verified
- Feb 2025
- First submitted
- 4 Jun 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Discharge Pharmacist-led Rapid Medication Optimization for Heart Failure (Post-Discharge PHARM-HF): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06450522
- Acronym / sponsor ID
- H24-00300
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will recruit 100 patients from a post-discharge medicine clinic to test if the addition of a pharmacist to manage heart failure medications can increase appropriate use of these medications. Participants will be randomly assigned to usual care alone or with the addition of a pharmacist to help manage medications. They will be followed for 3 months by telephone/electronically-administered questionnaires, and 12 months using administrative health records. Outcome data will include information from patients on quality of life, treatment burden, medication adherence, as well as information from their medical record on heart failure events.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist co-management | Experimental | Other: Pharmacist co-management of HF medication optimizationIn addition to usual care, participants with an initial Post-Discharge Medicine Clinic visit randomized to the intervention arm will receive pharmacist co-management of their medications, with the intent of to achieve rapid, maximum-tolerated pharmacotherapy for HF as outlined in the latest guidelines. This intervention will be delivered by a staff pharmacist at the St. Paul's Hospital, using the standard procedures outlined below: For HFrEF, where possible, a patient will be prescribed the combination of an ARNI, evidence-based beta-blocker, MRA, and SGLT2i at target HFrEF doses, along with personalized therapies as outlined in the 2021 CCS HF guidelines. For HFmrEF, we will target ACEI/ARB/ARNI, beta-blocker, MRA, and SGLT2i. For HFpEF, we will target SGLT2i + MRA +/- ACEI/ARB/ARNI. The intervention will incorporate key components identified in a systematic review of observational studies of pharmacist-led optimization of HF. |
| Usual care | Other | Other: Usual careUsual care: Both the intervention group and comparator group will receive usual care by the Post-Discharge Medicine Clinic, which does not include clinical pharmacy services. The standard pathway in the St. Paul's Hospital Post-Discharge Medicine Clinic consists of an initial consultation with the clinic internist within 2 weeks of discharge, followed by two visits approximately 1 week apart with the Post-Discharge Medicine Clinic internist, followed by discharge from the clinic. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥19 years;
- Attending their initial visit to the PDMC;
- Diagnosis of HF.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist co-management of HF medication optimizationIn addition to usual care, participants with an initial Post-Discharge Medicine Clinic visit randomized to the intervention arm will receive pharmacist co-management of their medications, with the intent of to achieve rapid, maximum-tolerated pharmacotherapy for HFrEF as outlined by the 2021 CCS HF guidelines, and for HFmrEF/HFpEF as outlined by the 2022 ACC/AHA HF guidelines. This intervention will be delivered by a staff pharmacist at the St. Paul's Hospital, using the standard procedures outlined below: For HFrEF: Where possible, a patient will be prescribed the combination of an ARNI, evidence-based beta-blocker, MRA, and SGLT2i at target HFrEF doses, along with personalized therapies as outlined in the 2021 CCS HF guidelines. For HFmrEF: We will target ACEI/ARB/ARNI+BB+MRA+SGLT2i. For HFpEF: We will target SGLT2i+MRA +/- ACEI/ARB/ARNI. The intervention will incorporate key components identified in a systematic review of observational studies of pharmacist-led optimization of HF. | Other | Pharmacist co-management |
| Usual careUsual care | Other | Usual care |
Primary outcome
Optimization Potential Score
Time frame: 3 months
Score that quantifies guideline-directed medical therapy (GDMT) use in heart failure with reduced ejection fraction. The score ranges from 0 (worst) to 10 (best). For HFmrEF, this will be modified to assign equal weight to ACEI/ARB/ARNI (score range 0-8). For HFpEF, this will be further modified to assign equal weight to ACEI/ARB/ARNI, and to assign no points for beta-blocker use (score range 0-6).
1 secondary outcome
Composite hierarchical outcome
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Heart Failure with Reduced Ejection Fraction HFrEF
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Not yet recruitingObservational study
Metabolic Changes in Heart Failure Patients Treated With Vericiguat
Heart Failure, Worsening Heart Failure
RecruitingPhase 2
Vsling™ I: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist co-management of HF medication optimization in people with Heart Failure with Reduced Ejection Fraction HFrEF, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimization Potential Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.