This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Goal Directed Medical Therapy for Device Clinic Patients With Reduced EF at UOHI: a QI Initiative (VIGILANT) (VIGILANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05085249
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : March 6, 2023
Sponsor:
Collaborators:
Novartis
Servier
AstraZeneca
Information provided by (Responsible Party):
Mehrdad Golian, Ottawa Heart Institute Research Corporation

Brief 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). 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.


Condition or disease
Heart Failure

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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)
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Goal directed medical therapy compliance [ Time Frame: 6 months ]
    Rate of compliance will be assessed in this initiative



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Patients with implantable cardioverter-defibrillator
  • Ejection fraction ≤ 35%

Exclusion Criteria:

  • None (QA project)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085249


Contacts
Layout table for location contacts
Contact: Mehrdad Golian, MD 6136967000 ext 67271 mgolian@ottawaheart.ca
Contact: Tammy Knight 6136967000 ext 19080 tknight@ottawaheart.ca

Locations
Layout table for location information
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Mehrdad Golian, MD    6136967000 ext 67271    mgolian@ottawaheart.ca   
Contact: Tammy Knight    6136967000 ext 19080    tknight@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Novartis
Servier
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: Mehrdad Golian, MD Ottawa Heart Institute Research Corporation
Layout table for additonal information
Responsible Party: Mehrdad Golian, Cardiologist, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05085249    
Other Study ID Numbers: 2021_Vigilant_QA
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: March 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehrdad Golian, Ottawa Heart Institute Research Corporation:
Quality assurance
Medication optimization
Device clinic
Cardiomyopathy
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases