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

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

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

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.

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