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



Status:Not yet recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/13/2018
Start Date:June 2018
End Date:December 2019
Contact:Carol E Hendrix, MSN, RN
Email:chendrix@cirquestlabs.com
Phone:901-866-1700

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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
We found this trial at
1
site
Memphis, Tennessee 38112
Principal Investigator: Lisa K Jennings, PhD
Phone: 901-866-1700
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mi
from
Memphis, TN
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