Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
NCT ID: NCT03551756
Last Updated: 2020-01-23
Study Results
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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UNKNOWN
120 participants
OBSERVATIONAL
2018-07-10
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
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
Exploratory Biomarker Analysis for cardiac patients versus healthy adults
Healthy Adult
Biomarker assessment in 20 healthy age-matched subjects
Biomarker Assessment
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
CirQuest Labs, LLC
OTHER
Responsible Party
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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
Stern Cardiovascular
Germantown, Tennessee, United States
CirQuest Labs, LLC
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CQ 17-11-009
Identifier Type: -
Identifier Source: org_study_id
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