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

Study Overview
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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.

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

Conditions
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Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease

Intervention / Treatment
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* Other: Biomarker Assessment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure & Coronary Artery Disease<br>Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease | Other: Biomarker Assessment<br>* Exploratory Biomarker Analysis for cardiac patients versus healthy adults<br>|
| Healthy Adult<br>Biomarker assessment in 20 healthy age-matched subjects | Other: Biomarker Assessment<br>* Exploratory Biomarker Analysis for cardiac patients versus healthy adults<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker assessment | Exploratory biomarker analysis | 1 day |