Assessment of Biomarkers in Patients With Decompensated Heart Failure and Underlying Coronary Artery Disease
1 other identifier
observational
120
1 country
3
Brief Summary
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2018
CompletedFirst Posted
Study publicly available on registry
June 11, 2018
CompletedStudy Start
First participant enrolled
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJanuary 23, 2020
January 1, 2020
2 years
May 29, 2018
January 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarker assessment
Exploratory biomarker analysis
1 day
Study Arms (2)
Heart Failure & Coronary Artery Disease
Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease
Healthy Adult
Biomarker assessment in 20 healthy age-matched subjects
Interventions
Exploratory Biomarker Analysis for cardiac patients versus healthy adults
Eligibility Criteria
100 subjects with the study diagnosis and 20 healthy age-matched subjects, no restrictions on gender, race, or ethnicity
You may qualify if:
- 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
- % 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CirQuest Labs, LLClead
- Janssen Scientific Affairs, LLCcollaborator
Study Sites (3)
University of Florida
Jacksonville, Florida, 32209, United States
Stern Cardiovascular
Germantown, Tennessee, 38138, United States
CirQuest Labs, LLC
Memphis, Tennessee, 38112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa K. Jennings, PhD
CirQuest Labs, LLC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2018
First Posted
June 11, 2018
Study Start
July 10, 2018
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
January 23, 2020
Record last verified: 2020-01