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

• Conditions: Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction
• Interventions: Other: Biomarker Assessment

• Registration Number: NCT03551756
• Lead Sponsor: CirQuest Labs, LLC

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.

Study Timeline

• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-11
• Study Start: 2018-07-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart Failure & Coronary Artery Disease	Biomarker Assessment	Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease
Healthy Adult	Biomarker Assessment	Biomarker assessment in 20 healthy age-matched subjects

Primary Outcome Measures

Name	Time	Method
Biomarker assessment	1 day	Exploratory biomarker analysis

Trial Locations

Locations (3)

University of Florida; 🇺🇸 Jacksonville, Florida, United States

Stern Cardiovascular; 🇺🇸 Germantown, Tennessee, United States

CirQuest Labs, LLC; 🇺🇸 Memphis, Tennessee, United States