CClinicalTrials.gg
Status unknownNCT03551756Updated Jan 23, 2020

Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease

An observational study in Heart Failure With Reduced Ejection Fraction and Coronary Artery Disease, sponsored by CirQuest Labs, LLC. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-23.

Sponsored by CirQuest Labs, LLC · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease

Read the detailed description

This is a cross-sectional, single center exploratory study of plasma biomarker levels in adults with decompensated heart failure and significant underlying coronary artery disease as compared with age-matched healthy controls. Subjects will not receive a therapeutic treatment as part of this study and will undergo a single blood draw.

02

Conditions studied

  • Heart Failure With Reduced Ejection Fraction
  • Coronary Artery Disease
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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 120 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

CirQuest Labs, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

100 subjects with the study diagnosis and 20 healthy age-matched subjects, no restrictions on gender, race, or ethnicity

Inclusion criteria

Group 1: Heart Failure with Coronary Artery Disease Subjects

  • Symptomatic heart failure (≥ 3 months) with most recently documented LVEF ≤ 40% (Echo must have been completed in last 12 months prior to enrollment.)
  • Significant underlying coronary artery disease as evidenced by:
  • previous myocardial infarction
  • prior coronary artery bypass graft
  • 50% coronary stenosis of one or more arteries and/or
  • history of percutaneous coronary intervention with or without stenting
  • Age 18 years or older at the first screening visit

Group 2: Healthy Subjects

  • Age 18 years or older at the first screening visit and within 20% of mean age of Group 1 Subjects

Exclusion criteria

Exclusion Criteria:

Group 1:

  • Documented history of "severe" valvular disease
  • Documented history of atrial fibrillation, ventricular fibrillation or ventricular tachycardia.
  • Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)

Group 2:

  • Known significant cardiovascular or hematological condition
  • Recent or current use of anticoagulant medications such as fXa inhibitors, direct thrombin inhibitors, vitamin K antagonists, or heparin. (within 1 month of screening)
  • Recent cold or flu symptoms, respiratory infection or surgery (within 2 weeks of screening)
  • History of Asthma
  • History of peptic ulcers
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Heart Failure & Coronary Artery Disease

    Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease

    Other: Biomarker Assessment

  • Healthy Adult

    Biomarker assessment in 20 healthy age-matched subjects

    Other: Biomarker Assessment

Interventions

  • OtherBiomarker Assessment

    Exploratory Biomarker Analysis for cardiac patients versus healthy adults

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What researchers measure

Primary outcomes

  1. Biomarker assessment

    Exploratory biomarker analysis

    Time frame: 1 day

07

Study locations

3 of 3 sites recruiting
  • University of Florida
    Jacksonville, Florida 32209, United States
    Recruiting
  • Stern Cardiovascular
    Germantown, Tennessee 38138, United States
    Recruiting
  • CirQuest Labs, LLC
    Memphis, Tennessee 38112, United States
    • Carol E Hendrix, MSN, RN · Contact · chendrix@cirquestlabs.com · 901-866-1700
    • Edward Hord, BSN, RN · Contact · ehord@cirquestlabs.com · 901-866-1700
    • Lisa K Jennings, PhD · Principal investigator
    • Rick Alleman, PhD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03551756
Lead sponsor
CirQuest Labs, LLC
Collaborators
Janssen Scientific Affairs, LLC
Responsible party
Sponsor
First posted
Jun 11, 2018
Start date
Jul 10, 2018
Primary completion
Jul 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Jan 23, 2020

Study contacts

Carol E Hendrix, MSN, RN
Contact
chendrix@cirquestlabs.com
901-866-1700
Edward Hord, BSN, RN
Contact
ehord@cirquestlabs.com
901-866-1700
Lisa K. Jennings, PhD
principal investigator · CirQuest Labs, LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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