AzTrials
AzTrials

Heart FailureNCT05224557

Analysis of Cardiac Biomarker Racial Discrepancies

An observational study of Heart Failure, run by Methodist Health System at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
0 participants
Where
1 siteUnited States
Study dates
15 Sep 2021to 15 Sep 2028
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 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • >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

Who cannot join

  • Patients not meeting inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Methodist Dallas Medical Center

    Dallas, Texas, 75203

Other trials in United States

About this study

Official title: Analysis of Cardiac Biomarker Racial Discrepancies in African American Patients With Heart Failure With Reduced Ejection Fraction

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.

Read the detailed description

Limited data exists on the overall impact racial and genetic differences play on expression of cardiac biomarkers, especially natriuretic peptides (NPs). NPs like atrial NP, brain NP (BNP), and C-type NP are endogenous hormones with powerful cardiovascular and metabolic effects. NPs play an active role in natriuresis and vasodilation along with lipolysis, weight loss, and insulin sensitivity, whereas NP deficiencies correlate with increased risk for developing cardiovascular comorbidities like hypertension. Many cardiac disease states like acute coronary syndrome, valvular heart disease (VHD), and atrial fibrillation (AFib) can cause significant elevations in NPs. Elevated NP levels have also been associated with liver cirrhosis, chronic renal dysfunction, and infectious sepsis. However, NP elevations are most commonly associated with heart failure (HF), and increasing BNP levels have been correlated with increasing grades of cardiac dysfunction and end-diastolic wall stress within the heart.

African American (AA) patients experience higher incidence of HF relative to the general population and are at an increased risk of mortality secondary to chronic HF compared to Caucasian patients. AA patients are three times more likely to develop HF because AA patients may suffer from a subgroup of left ventricular hypertrophy where biomarkers like N-terminal pro-BNP (NT-proBNP) are not clinically elevated. The 2021 American College of Cardiology/American Heart Association Heart Failure with Reduced Ejection Fraction (HFrEF) Treatment Guidelines endorse measurement of both BNP and NT-proBNP as biomarkers for the diagnosis and prognostication of HF; however, current treatment guidelines have not established treatment thresholds for either BNP or NT-proBNP.7 The Food and Drug Administration (FDA) approved cutoff BNP value for the diagnosis of HF is 100 pg/mL. For NT-proBNP, the optimal cutoff values for confirmatory decision limits for HF are 450, 900, and 1,800 pg/mL for ages less than 50 years, between 50 to 75 years, and older than 75 years of age, respectively.3 In clinical practice, significant heterogeneity surrounds treatment cutoffs for NT-proBNP levels for treatment of HF, as seen in many recent prominent landmark HF pharmacotherapy trials.

Within the general population, serum NP levels, especially NT-proBNP, are significantly lower in the AA population compared to Caucasians as seen in the Reasons for Geographic and Racial Differences in Stroke, Dallas Heart, and Atherosclerosis Risk in Communities studies. After accounting for traditional risk factors, racial differences in body composition, cardiac structure, and socioeconomic factors, AA patients were found to have significantly lower serum NT-proBNP levels and greater levels of markers of myocardial stress and inflammation, including high-sensitivity Troponin T (hsTnT), Growth Differentiation Factor 15 (GDF-15), and Suppression of Tumorigenicity 2(ST2). This finding may also be due to genetic differences, as percent European ancestry (PEA) in AA patients was found to have a direct impact on NT-proBNP levels in the general AA population. Of the 1656 AA patients in whom PEA data were available, a 10% increase in PEA was associated with 7% higher adjusted NT-proBNP levels.

Knowing that the general AA population has lower serum NP's compared to Caucasian patients, limited research focuses on initial NT-proBNP levels in AA patients with new-onset HF. Given that many landmark HF trials primarily enroll Caucasian patients, several questions emerge: (i) should medicine individualize treatment thresholds for NT-proBNP and other cardiac biomarkers based on race given known racial discrepancies with serum NP's and increased mortality seen in these patients? (ii) Is the trend seen in AA patients regarding serum NPs and other cardiac biomarkers still true when these patients present with new-onset HF? Our goal is to review cardiac biomarkers present on admission between AA patients with new onset HF 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 HF severity.

Conditions
Heart Failure
Being tested
No intervention
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT05224557
Study groupRoleWhat they receive
New onset HFrEF AA patientsNew onset HFrEF AA patients
Receives: Other: No intervention
New onset HFrEF Caucasian patientsNew onset HFrEF Caucasian patients
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline NT-proBNP levels on admission

    Collection of baseline blood tests

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

  2. Baseline troponin-I or troponin-T levels on admission

    Collection of baseline blood tests

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

  3. Demographic data: Age

    Age of subject in years

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

  4. Demographic data: Gender

    male or female

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

  5. Demographic data: body mass index (BMI)

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

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

  6. 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.

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

  7. New York Heart Association (NYHA) class

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start15 Sep 2021
  3. Primary completion15 Aug 2027 (estimated)
  4. Study completion15 Sep 2028 (estimated)

Why it stopped: PI no longer with the site

Resources

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
Retrospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05224557
Sponsor's protocol ID
043.PHA.2021.A
Status last verified
Jun 2026
First submitted
3 Feb 2022
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Methodist Health System at 1 site in United States.

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 7 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: withdrawn, as of the sponsor's last update on 4 Aug 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 United States. 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 was withdrawn before enrolling participants, so there are no results.

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?

Baseline NT-proBNP levels on admission (time frame: Chart reviews ill be done for charts generated from April 2017 to August 2020). The study lists 7 primary outcomes in all. 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 4 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in