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

CirQuest Labs

Status: Unknown

Conditions: Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction

Treatments: Other: Biomarker Assessment

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03551756

CQ 17-11-009

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Heart Failure & Coronary Artery Disease

Description:

Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease

Treatment:

Other: Biomarker Assessment

Healthy Adult

Description:

Biomarker assessment in 20 healthy age-matched subjects

Treatment:

Other: Biomarker Assessment