Studies of Neuregulin/ERBB Signaling in Human Heart

November 22, 2022 updated by: Douglas B. Sawyer

Isolation and Characterization of ERBB Expressing Human Heart Progenitor Cells

This study examines the role of the epidermal growth factor (EGF) receptor family and the EGF family of ligands in the regulation of non-myocytes isolated from the human heart.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The EGF family of receptor tyrosine kinases (a.k.a. ERBB receptors) mediate the effects of the epidermal growth factor (EGF) family including Neuregulin-1β (NRG). NRG and ERBB1-4 are critical for cardiac development and maintenance of the adult heart. Current understanding of the role of EGF/NRG/ERBB signaling in the cardiovascular system is rapidly evolving due to recent findings in non-myocyte cell populations. This study is examining a population of progenitor cells in the adult human heart that responds to EGF and NRG. Subjects are enrolled who are scheduled to undergo heart surgery and are willing to allow for a small biopsy to be taken from their hearts during surgery. Biopsies are taken to the laboratory where cells are separated and analyzed by flow cytometry and grown in cell culture to understand how their biology is regulated by NRG and EGF.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center
        • Contact:

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with coronary artery disease with scheduled coronary artery bypass surgery.

Description

Inclusion Criteria:

  • Clinical diagnosis of severe coronary artery disease scheduled to undergo coronary artery bypass surgery.

Exclusion Criteria:

  • less than 18 years of age
  • unwilling or unable to provide informed consent
  • known active myocarditis
  • hypertrophic cardiomyopathy
  • constrictive pericarditis or other significant pericardial disease
  • severe pulmonary hypertension
  • significant renal impairment (Cr > 2.5 mg/dL)
  • severe ventricular arrhythmias
  • pregnancy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of highly proliferative clones isolated
Time Frame: up to 14 days from isolation
up to 14 days from isolation

Secondary Outcome Measures

Outcome Measure
Time Frame
Flow cytometric ERBB receptor expression in highly proliferative clones isolated from heart tissue
Time Frame: up to 14 days from isolation
up to 14 days from isolation

Collaborators and Investigators

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

Sponsor

Douglas B. Sawyer

Collaborators

MaineHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2024

Study Completion (ANTICIPATED)

June 1, 2025

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (ESTIMATE)

June 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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