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

NCT ID: NCT03551756

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-10

Study Completion Date

2020-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Failure With Reduced Ejection Fraction Coronary Artery Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Heart Failure & Coronary Artery Disease

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

Biomarker Assessment

Intervention Type OTHER

Exploratory Biomarker Analysis for cardiac patients versus healthy adults

Healthy Adult

Biomarker assessment in 20 healthy age-matched subjects

Biomarker Assessment

Intervention Type OTHER

Exploratory Biomarker Analysis for cardiac patients versus healthy adults

Interventions

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Biomarker Assessment

Exploratory Biomarker Analysis for cardiac patients versus healthy adults

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role collaborator

CirQuest Labs, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa K. Jennings, PhD

Role: PRINCIPAL_INVESTIGATOR

CirQuest Labs, LLC

Locations

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University of Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Stern Cardiovascular

Germantown, Tennessee, United States

Site Status RECRUITING

CirQuest Labs, LLC

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Carol E Hendrix, MSN, RN

Role: CONTACT

901-866-1700

Edward Hord, BSN, RN

Role: CONTACT

901-866-1700

Facility Contacts

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Latonya Been

Role: primary

904-244-4520

Brian Dragutsky

Role: primary

901-271-1000

Rishi Bhula

Role: backup

901-271-1000

Carol E Hendrix, MSN, RN

Role: primary

901-866-1700

Edward Hord, BSN, RN

Role: backup

901-866-1700

Other Identifiers

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CQ 17-11-009

Identifier Type: -

Identifier Source: org_study_id

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