Clinical trial NCT03551756: Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
Official title: Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure With Reduced Ejection Fraction
Coronary Artery Disease
Lead sponsor: CirQuest Labs, LLC
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2018-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 subjects with the study diagnosis and 20 healthy age-matched subjects, no restrictions on gender, race, or ethnicity

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biomarker assessment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Germantown
country: United States
facility: Stern Cardiovascular
state: Tennessee
city: Memphis
country: United States
facility: CirQuest Labs, LLC
state: Tennessee
Study officials:
affiliation: CirQuest Labs, LLC
name: Lisa K. Jennings, PhD
role: PRINCIPAL_INVESTIGATOR
References: