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Studies of Neuregulin/ERBB Signaling in Human Heart

Sponsor
Douglas B. Sawyer (Other)
Overall Status
Recruiting
CT.gov ID
NCT02820233
Collaborator
MaineHealth (Other)
80
Enrollment
1
Location
120
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Isolation and Characterization of ERBB Expressing Human Heart Progenitor Cells
    Actual Study Start Date :
    Jun 1, 2015
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. The number of highly proliferative clones isolated [up to 14 days from isolation]

    Secondary Outcome Measures

    1. Flow cytometric ERBB receptor expression in highly proliferative clones isolated from heart tissue [up to 14 days from isolation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maine Medical Center Portland Maine United States 04102

    Sponsors and Collaborators

    • Douglas B. Sawyer
    • MaineHealth

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douglas B. Sawyer, Chief Academic Officer, MaineHealth
    ClinicalTrials.gov Identifier:
    NCT02820233
    Other Study ID Numbers:
    • 4590
    First Posted:
    Jun 30, 2016
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Heart Diseases
    Vascular Diseases

    Study Results

    No Results Posted as of Jul 6, 2022