Analysis of Cardiac Biomarker Racial Discrepancies

NCT05224557 | Enrolling By Invitation

• 1 other identifier: 043.PHA.2021.A
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (7)

• Baseline NT-proBNP levels on admission

  Collection of baseline blood tests

  Chart reviews ill be done for charts generated from April 2017 to August 2020

• Baseline troponin-I or troponin-T levels on admission

  Collection of baseline blood tests

  Chart reviews ill be done for charts generated from April 2017 to August 2020

• Demographic data: Age

  Age of subject in years

  Chart reviews ill be done for charts generated from April 2017 to August 2020

• Demographic data: Gender

  male or female

  Chart reviews ill be done for charts generated from April 2017 to August 2020

• Demographic data: body mass index (BMI)

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

  Chart reviews ill be done for charts generated from April 2017 to August 2020

• Ejection Fraction on echocardiography during first admission

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

  Chart reviews ill be done for charts generated from April 2017 to August 2020

• New York Heart Association (NYHA) class

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

  Chart reviews ill be done for charts generated from April 2017 to August 2020

Study Arms (2)

New onset HFrEF AA patients

New onset HFrEF AA patients

Other: No intervention

New onset HFrEF Caucasian patients

New onset HFrEF Caucasian patients

Other: No intervention

Interventions

No intervention OTHER

No intervention

New onset HFrEF AA patients; New onset HFrEF Caucasian patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects that self-identify as African American or Caucasian with a new onset of Heart Failure with Reduced Ejection Fraction

You may qualify if:

• \>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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Crystal Brown, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 4, 2022
• Study Start: September 15, 2021
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): September 15, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)