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Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease | Clinical Trials | Clareo Health

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

NCT03551756•CirQuest Labs, LLC

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

•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

Locations (3)

University of Florida

Jacksonville, Florida, United States

Stern Cardiovascular

Germantown, Tennessee, United States

CirQuest Labs, LLC

Memphis, Tennessee, United States

Key Dates

Start Date

July 10, 2018

Primary Completion Date

July 1, 2020

Completion Date

July 1, 2020

Last Updated

January 23, 2020

Enrollment

120

ESTIMATED participants

Conditions

Heart Failure With Reduced Ejection FractionCoronary Artery Disease

Interventions

Biomarker Assessment

OTHER

Contacts

Carol E Hendrix, MSN, RN

CONTACT

901-866-1700 chendrix@cirquestlabs.com

Edward Hord, BSN, RN

CONTACT

901-866-1700 ehord@cirquestlabs.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

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