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Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System (Yale-HF)

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: NCT04237701
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
The Yale HF Registry is a live EHR based registry that allows for retrospective and real-time monitoring of Heart Failure case across the Yale New Haven Health System.

Condition or disease
Heart Failure Heart Failure With Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction Heart Failure NYHA Class IV

Detailed Description:
Electronic Health Records based registries can be an important resource for precision medicine delivery by understanding the population burden of chronic diseases such as heart failure. These registries can allow for a deeper understanding of gaps in guideline recommended therapies among patients who are under the purview of large, integrated Therefore, we have created a live registry within the integrated Yale New Haven Health System—the Yale Heart Failure Registry—that includes all patients with a diagnosis of HF and has detailed information about demographics, comorbidities, laboratories, imaging, medications, and clinical outcomes (including hospital readmissions). The registry is updated daily and can be queried for clinically relevant questions aimed at quality improvement.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Retrospective and Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System Via a Live Registry
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Hospitalization [ Time Frame: 10 years ]
    Heart Failure hospitalizations

  2. Doses of therapies that comprise guideline directed medical therapy [ Time Frame: 10 years ]
    Appropriate use of guideline recommended therapies. This will include doses of beta blockers, ACE inhibitors, ARBs, ARNI, SGLT2i, ICD use.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Retrospective and Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System Via a Live Registry
Criteria

Inclusion Criteria:

  • Seen within the Yale New Haven Health System
  • Diagnosis of heart failure

Exclusion Criteria:

  • Age<18
Contacts and Locations
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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): NCT04237701


Contacts
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Contact: Tariq Ahmad, MD MPH (203) 843-1667 Tariq.ahmad@yale.edu
Contact: Nihar Desai, MD MPH 203-767-6399

Locations
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United States, Connecticut
Yale New Haven Health System Recruiting
New Haven, Connecticut, United States, 06510
Contact: Tariq Ahmad, MD MPH    203-843-1667    tariq.ahmad@yale.edu   
Contact: Nihar Desai, MD MPH    2037676399    nihar.desai@yale.edu   
Principal Investigator: Tariq Ahmad, MD MPH         
Principal Investigator: Nihar Desai, MD MPH         
Sponsors and Collaborators
Yale University
Investigators
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Study Director: Nihar Desai, MD MPH Yale University
Principal Investigator: Tariq Ahmad, MD MPH Yale University
More Information
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Publications of Results:

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04237701    
Other Study ID Numbers: 2000026771
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data is on patients seen at Yale New Haven Health system and will be used for quality improvement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases