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Completed
NCT03551756
Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
Conditions: Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 94
Sponsor: CirQuest Labs, LLC
Location: University of Florida Jacksonville Florida
Summary
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT03551756). StuddyBuddy aggregates publicly available trial information.