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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03551756
• Other study ID #: CQ 17-11-009
• Status: Recruiting
• Start date: July 10, 2018
• Est. completion date: July 2020

Study information

• Verified date: January 2020
• Source: CirQuest Labs, LLC
• Contact: Carol E Hendrix, MSN, RN
• Phone: 901-866-1700
• Email: chendrix[@]cirquestlabs.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Myocardial Ischemia

Intervention

Other:
• Biomarker Assessment
Exploratory Biomarker Analysis for cardiac patients versus healthy adults

Locations

Country	Name	City	State
United States	Stern Cardiovascular	Germantown	Tennessee
United States	University of Florida	Jacksonville	Florida
United States	CirQuest Labs, LLC	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
CirQuest Labs, LLC	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker assessment	Exploratory biomarker analysis	1 day