Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
Conditions
Brief summary
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease
Detailed description
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.
Interventions
OTHERBiomarker Assessment
Exploratory Biomarker Analysis for cardiac patients versus healthy adults
Sponsors
Janssen Scientific Affairs, LLC
CirQuest Labs, LLC
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker assessment | 1 day | Exploratory biomarker analysis |
Countries
United States
Contacts
Primary ContactCarol E Hendrix, MSN, RN
Backup ContactEdward Hord, BSN, RN
Outcome results
None listed