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Analysis of Cardiac Biomarker Racial Discrepancies

Sponsor
Methodist Health System (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05224557
Collaborator
(none)
400
Enrollment
1
Location
12
Anticipated Duration (Months)
33.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal is to review cardiac biomarkers present on admission between African American patients with new onset Heart Failure compared to a comparable cohort of Caucasian patients to establish whether there is a clinically significant difference between the two groups regarding cardiac biomarker levels and initial Heart Failure severity.

Hypothesis: Cardiac biomarker levels in African American patients with new onset Heart Failure with Reduced Ejection Fraction will be significantly lower than a Caucasian cohort with new onset Heart Failure with Reduced Ejection Fraction.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Analysis of Cardiac Biomarker Racial Discrepancies in African American Patients With Heart Failure With Reduced Ejection Fraction
Actual Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

Arm Intervention/Treatment
New onset HFrEF AA patients

Other: No intervention
No intervention
New onset HFrEF Caucasian patients

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. Baseline NT-proBNP levels on admission [Chart reviews ill be done for charts generated from April 2017 to August 2020]

    Collection of baseline blood tests

  2. Baseline troponin-I or troponin-T levels on admission [Chart reviews ill be done for charts generated from April 2017 to August 2020]

    Collection of baseline blood tests

  3. Demographic data: Age [Chart reviews ill be done for charts generated from April 2017 to August 2020]

    Age of subject in years

  4. Demographic data: Gender [Chart reviews ill be done for charts generated from April 2017 to August 2020]

    male or female

  5. Demographic data: body mass index (BMI) [Chart reviews ill be done for charts generated from April 2017 to August 2020]

    BMI is calculated by taking the weight in kilograms divided by height in meters squared

  6. Ejection Fraction on echocardiography during first admission [Chart reviews ill be done for charts generated from April 2017 to August 2020]

    The patient has an EF <40% on echocardiography and is not on goal-directed medical therapy for HFrEF.

  7. New York Heart Association (NYHA) class [Chart reviews ill be done for charts generated from April 2017 to August 2020]

    Doctors usually classify patients' heart failure according to the severity of their symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:

  • 18 years

  • Self-identified as AA

  • Self-identified as Caucasian

  • NYHA class II-IV symptoms

  • Left ventricle EF <40%

  • First admission for HFrEF

  • No echocardiography during initial admission

Exclusion Criteria:
  • Patients not meeting inclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Crystal Brown, PharmD, Methodist Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT05224557
Other Study ID Numbers:
  • 043.PHA.2021.A
First Posted:
Feb 4, 2022
Last Update Posted:
Feb 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Feb 4, 2022