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

January 22, 2020 updated by: CirQuest Labs, LLC
Assessment of Biomarkers in Patients with Decompensated Heart Failure and Underlying Coronary Artery Disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Dominick J Angiolillo, MD
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Memphis, Tennessee, United States, 38112
        • Recruiting
        • CirQuest Labs, LLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa K Jennings, PhD
        • Sub-Investigator:
          • Rick Alleman, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart Failure & Coronary Artery Disease
Biomarker assessment in adults with decompensated heart failure and significant underlying coronary artery disease
Other: Biomarker Assessment
Exploratory Biomarker Analysis for cardiac patients versus healthy adults
Healthy Adult
Biomarker assessment in 20 healthy age-matched subjects
Other: Biomarker Assessment
Exploratory Biomarker Analysis for cardiac patients versus healthy adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker assessment
Time Frame: 1 day
Exploratory biomarker analysis
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CirQuest Labs, LLC

Collaborators

Janssen Scientific Affairs, LLC

Investigators

  • Principal Investigator: Lisa K. Jennings, PhD, CirQuest Labs, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQ 17-11-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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