Heart FailureVIGILANTNCT05085249
Improving Goal Directed Medical Therapy for Device Clinic Patients With Reduced EF at UOHI: a QI Initiative (VIGILANT)
An observational study of Heart Failure, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
This is a quality improvement initiative with the goal of optimizing heart failure (HF) patients seen through the outpatient cardiac implantable electronic device clinic at the University of Ottawa Heart Institute (UOHI). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 2,479 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2021to 31 Dec 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients seen at the University of Ottawa Heart Institute electronic device clinic who have an implantable cardioverter defibrillator device. Patients served are primarily from Ottawa and the surrounding region. As a tertiary care centre, UOHI also sees referrals from other regions across Canada.
Who may be able to join
- Patients with implantable cardioverter-defibrillator
- Ejection fraction ≤ 35%
Who cannot join
- None (QA project)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Goal Directed Medical Therapy for Device Clinic Patients With Reduced Ejection Fraction at the University of Ottawa Heart Institute: a Quality Improvement Initiative (VIGILANT)
This is a quality improvement initiative with the goal of optimizing heart failure (HF) patients seen through the outpatient cardiac implantable electronic device clinic at the University of Ottawa Heart Institute (UOHI). The UOHI device clinic oversees more than 12,000 in-clinic patient visits annually with over 5000 visits for patients with reduced ejection fraction (EF) and HF. In patients with reduced EF, guideline directed medical therapy compliance (GDMT) is sub-optimal in real world clinical practice. Considering the most recent changes to The Canadian Cardiovascular Society heart failure guideline recommendations, the compliance rate may be even lower than reported rates in the literature.
The goal of this study is to optimize GDMT through collaboration between the HF clinic, a HF/arrhythmia nurse practitioner, and application of a nurse run algorithm based pathway to identify patients suitable for medication optimization and guiding the most responsible physician (MRP) for their heart failure (PCP, cardiologist or HF physician) through a letter. The compliance rate will also be re-evaluated to assess improvement in GDMT in this patient population. GDMT will ensure the greatest chance to improve patient outcomes by reducing heart failure hospitalizations, emergency room visits, ventricular arrhythmias, implantable cardioverter defibrillator shocks, clinic visits, and thereby improving patients' quality of life.
Read the detailed description
The goal of this quality improvement initiative is to optimize goal directed medical therapy compliance (GDMT) in heart failure (HF) patients seen at the University of Ottawa Heart Institute (UOHI) device clinic. GDMT is reported as low as 45% and a recent Canadian survey reports estimated compliance as low as 15%. The project will be performed in 3 phases. Phase 1 will aim to establish the rates of GDMT compliance in heart failure patients seen through the device clinic. The chart of 600 consecutive implantable cardioverter defibrillator (ICD) patients will be reviewed to establish the current compliance rate with GDMT in patients with reduced ejection fraction (EF). In Phase 2, the goal is to optimize GDMT through collaboration between the HF clinic and a nurse run algorithm based pathway to identify patients suitable for medication optimization and guiding the most responsible physician (MRP) for their heart failure (PCP, cardiologist or HF physician) through a letter. The ultimate goal is to improve the quality of life of patients seen at the institute. In Phase 3, the compliance rate will be re-evaluated every 6 months to assess for improvement in GDMT in this patient population.
During Phase 1 (establishing baseline medication compliance), the charts of 600 consecutive ICD patients will be reviewed using PACeART and EPIC databases. Rate of GDMT compliance will be calculated. For the purposes of this investigation, and in patients with EF < 40% at the time of ICD clinic visit, GDMT is defined as:
- NHYA I and ACE-I/ARB OR ARNI+BB+MRA+SGL2 or
- NYHA II or above and on ARNI+BB+MRA+SGL2
ACE-I refers to Angiotensin-converting-enzyme inhibitor medication, ARB refers to Angiotensin II receptor blocker medication, ARNI refers to angiotensin receptor neprilysin inhibitor medication, BB refers to beta blocker medication, MRA refers to aldosterone receptor antagonist medication, and SGL2 refers to sodium-glucose cotransporter-2 inhibitor medication.
During Phase 2 (medication optimization through collaborative work with heart function clinic, primary cardiologist and device clinic), all patients seen with ICD and reduced EF at the UOHI device clinic will be given a questionnaire by the clinic assistant. The questionnaire will be comprised of 2 questions:
- Does ordinary physical activity (i.e. walking to the device clinic, grocery shopping, etc.) cause palpitation, fatigue, shortness of breath or chest pain? (yes/no)
- Have you been admitted to the hospital for heart failure in the past year? (yes/no)
If patient has answered no to both questions of the survey they will be classified as NYHA I, all others will be classified as NYHA II or greater. Medication lists will be updated for all patients by the device clinic nurse in EPIC. Blood pressure and pulse will also be documented in EPIC by the device clinic nurse for all in-person appointments. A clinical nurse or physician assistant will review all patient visits for ICD and reduced EF at the UOHI device clinic, patients not on GDMT (defined above) will have a letter sent to their cardiologist with recommendations on medication change and required follow up. Those without a cardiologist will be referred to the heart function clinic at UOHI or general hospital for medication optimization. Patients will be categorized into 4 groups:
- Patients on GDMT and at target dose (no action required) Those on GDMT will continue on the same medication with no change. In patients with EF < 40% at the time of ICD clinic visit, GDMT is defined as:
- NHYA I and ACE-I/ARB OR ARNI+BB+MRA+SGL2 or
- NYHA II or above and on ARNI+BB+MRA+SGL2
- Patients that require up titration of medication. These patients have been identified as NYHA II or above and they are not on the target dose of medication. A quality officer reviews the answers to the questionnaire, their current medications, and if systolic blood pressure > 100 mmHg. a letter of will be sent to the pts cardiologist and a copy will be given to the patient regarding medication optimization recommendation and required follow up. Medication doses and required follow up will be detailed in the letter.
- Patient requires a change in medication but has not cardiologist. A referral will be made by the nurse or physician's assistant to the UOHI heart function clinic for medication optimization for patients identified as NYHA II or above and require initiation of ANRI, SGL2, BB, or MRA. Blood requisition will also be given to and results will be sent to the referred MD. All patients who have their medication increased or referred to have their medication switched and up titrated through the heart function medication optimization clinic will have a letter sent to their care team (cardiologist and family physician) informing them of the referral and change in medication.
- Patients already actively followed by the HF clinic will have an appointment made with their HF cardiologist.
During Phase 3 (re-evaluation), patients will bring the letter from their cardiologist stating the reason why they were not started on the recommended medication (i.e. renal function, patient preference, urinary tract infection, low blood pressure, hyperkalemia etc.). The medication use will be rated every 6 months through EPIC to assess for increase in medication uptake. In addition, annually 35 (approximately 10% of the ICD implants) randomly selected ICD patients with reduced ejection fraction from the device clinic will be assessed regarding GDMT.
- Conditions
- Heart Failure
- Keywords
- Quality assurance, Medication optimization, Device clinic, Cardiomyopathy
- Medical subject headings
- Heart Failure, Cardiomyopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal directed medical therapy compliance
Rate of compliance will be assessed in this initiative
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start14 Jul 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,479 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Servier, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Mehrdad Golian, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085249
- Sponsor's protocol ID
- 2021_Vigilant_QA
- Acronym
- VIGILANT
- Status last verified
- Aug 2026
- First submitted
- 6 Oct 2021
- Last updated
- 30 Sep 2026
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Goal Directed Medical Therapy for Device Clinic Patients With Reduced Ejection Fraction at the University of Ottawa Heart Institute: a Quality Improvement Initiative (VIGILANT)
- ClinicalTrials.gov ID
- NCT05085249
- Acronym / sponsor ID
- VIGILANT / 2021_Vigilant_QA
- Conditions
- Heart Failure
- Keywords
- Quality assurance, Medication optimization, Device clinic, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,479 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Novartis, Servier, AstraZeneca
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Oct 2021 (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 is a quality improvement initiative with the goal of optimizing heart failure (HF) patients seen through the outpatient cardiac implantable electronic device clinic at the University of Ottawa Heart Institute (UOHI). The UOHI device clinic oversees more than 12,000 in-clinic patient visits annually with over 5000 visits for patients with reduced ejection fraction (EF) and HF. In patients with reduced EF, guideline directed medical therapy compliance (GDMT) is sub-optimal in real world clinical practice. Considering the most recent changes to The Canadian Cardiovascular Society heart failure guideline recommendations, the compliance rate may be even lower than reported rates in the literature.
The goal of this study is to optimize GDMT through collaboration between the HF clinic, a HF/arrhythmia nurse practitioner, and application of a nurse run algorithm based pathway to identify patients suitable for medication optimization and guiding the most responsible physician (MRP) for their heart failure (PCP, cardiologist or HF physician) through a letter. The compliance rate will also be re-evaluated to assess improvement in GDMT in this patient population. GDMT will ensure the greatest chance to improve patient outcomes by reducing heart failure hospitalizations, emergency room visits, ventricular arrhythmias, implantable cardioverter defibrillator shocks, clinic visits, and thereby improving patients' quality of life.
Detailed description
The goal of this quality improvement initiative is to optimize goal directed medical therapy compliance (GDMT) in heart failure (HF) patients seen at the University of Ottawa Heart Institute (UOHI) device clinic. GDMT is reported as low as 45% and a recent Canadian survey reports estimated compliance as low as 15%. The project will be performed in 3 phases. Phase 1 will aim to establish the rates of GDMT compliance in heart failure patients seen through the device clinic. The chart of 600 consecutive implantable cardioverter defibrillator (ICD) patients will be reviewed to establish the current compliance rate with GDMT in patients with reduced ejection fraction (EF). In Phase 2, the goal is to optimize GDMT through collaboration between the HF clinic and a nurse run algorithm based pathway to identify patients suitable for medication optimization and guiding the most responsible physician (MRP) for their heart failure (PCP, cardiologist or HF physician) through a letter. The ultimate goal is to improve the quality of life of patients seen at the institute. In Phase 3, the compliance rate will be re-evaluated every 6 months to assess for improvement in GDMT in this patient population.
During Phase 1 (establishing baseline medication compliance), the charts of 600 consecutive ICD patients will be reviewed using PACeART and EPIC databases. Rate of GDMT compliance will be calculated. For the purposes of this investigation, and in patients with EF < 40% at the time of ICD clinic visit, GDMT is defined as:
- NHYA I and ACE-I/ARB OR ARNI+BB+MRA+SGL2 or
- NYHA II or above and on ARNI+BB+MRA+SGL2
ACE-I refers to Angiotensin-converting-enzyme inhibitor medication, ARB refers to Angiotensin II receptor blocker medication, ARNI refers to angiotensin receptor neprilysin inhibitor medication, BB refers to beta blocker medication, MRA refers to aldosterone receptor antagonist medication, and SGL2 refers to sodium-glucose cotransporter-2 inhibitor medication.
During Phase 2 (medication optimization through collaborative work with heart function clinic, primary cardiologist and device clinic), all patients seen with ICD and reduced EF at the UOHI device clinic will be given a questionnaire by the clinic assistant. The questionnaire will be comprised of 2 questions:
- Does ordinary physical activity (i.e. walking to the device clinic, grocery shopping, etc.) cause palpitation, fatigue, shortness of breath or chest pain? (yes/no)
- Have you been admitted to the hospital for heart failure in the past year? (yes/no)
If patient has answered no to both questions of the survey they will be classified as NYHA I, all others will be classified as NYHA II or greater. Medication lists will be updated for all patients by the device clinic nurse in EPIC. Blood pressure and pulse will also be documented in EPIC by the device clinic nurse for all in-person appointments. A clinical nurse or physician assistant will review all patient visits for ICD and reduced EF at the UOHI device clinic, patients not on GDMT (defined above) will have a letter sent to their cardiologist with recommendations on medication change and required follow up. Those without a cardiologist will be referred to the heart function clinic at UOHI or general hospital for medication optimization. Patients will be categorized into 4 groups:
- Patients on GDMT and at target dose (no action required) Those on GDMT will continue on the same medication with no change. In patients with EF < 40% at the time of ICD clinic visit, GDMT is defined as:
- NHYA I and ACE-I/ARB OR ARNI+BB+MRA+SGL2 or
- NYHA II or above and on ARNI+BB+MRA+SGL2
- Patients that require up titration of medication. These patients have been identified as NYHA II or above and they are not on the target dose of medication. A quality officer reviews the answers to the questionnaire, their current medications, and if systolic blood pressure > 100 mmHg. a letter of will be sent to the pts cardiologist and a copy will be given to the patient regarding medication optimization recommendation and required follow up. Medication doses and required follow up will be detailed in the letter.
- Patient requires a change in medication but has not cardiologist. A referral will be made by the nurse or physician's assistant to the UOHI heart function clinic for medication optimization for patients identified as NYHA II or above and require initiation of ANRI, SGL2, BB, or MRA. Blood requisition will also be given to and results will be sent to the referred MD. All patients who have their medication increased or referred to have their medication switched and up titrated through the heart function medication optimization clinic will have a letter sent to their care team (cardiologist and family physician) informing them of the referral and change in medication.
- Patients already actively followed by the HF clinic will have an appointment made with their HF cardiologist.
During Phase 3 (re-evaluation), patients will bring the letter from their cardiologist stating the reason why they were not started on the recommended medication (i.e. renal function, patient preference, urinary tract infection, low blood pressure, hyperkalemia etc.). The medication use will be rated every 6 months through EPIC to assess for increase in medication uptake. In addition, annually 35 (approximately 10% of the ICD implants) randomly selected ICD patients with reduced ejection fraction from the device clinic will be assessed regarding GDMT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seen at the University of Ottawa Heart Institute electronic device clinic who have an implantable cardioverter defibrillator device. Patients served are primarily from Ottawa and the surrounding region. As a tertiary care centre, UOHI also sees referrals from other regions across Canada.
Key inclusion criteria (2 listed)
- Patients with implantable cardioverter-defibrillator
- Ejection fraction ≤ 35%
Key exclusion criteria (1 listed)
- None (QA project)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Goal directed medical therapy compliance
Time frame: 6 months
Rate of compliance will be assessed in this initiative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Mehrdad Golian, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Ottawa Heart Institute Research Corporation 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 2 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: finished, as of the sponsor's last update on 30 Sep 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Goal directed medical therapy compliance (time frame: 6 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 30 Sep 2026.