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Studies of Neuregulin/ERBB Signaling in Human Heart

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ClinicalTrials.gov Identifier: NCT02820233
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Douglas B. Sawyer, Maine Medical Center

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
Heart Disease Vascular Disease Heart Failure

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
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2025



Primary Outcome Measures :
  1. The number of highly proliferative clones isolated [ Time Frame: up to 14 days from isolation ]

Secondary Outcome Measures :
  1. Flow cytometric ERBB receptor expression in highly proliferative clones isolated from heart tissue [ Time Frame: up to 14 days from isolation ]

Biospecimen Retention:   Samples With DNA
Plasma, circulating monocytes, and cardiac tissue.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with coronary artery disease with scheduled coronary artery bypass surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820233


Locations
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Joanne Burgess, RN    207-662-2414    BURGEJS@mmc.org   
Sponsors and Collaborators
Maine Medical Center

Responsible Party: Douglas B. Sawyer, Chief of Cardiac Services, Maine Medical Center
ClinicalTrials.gov Identifier: NCT02820233     History of Changes
Other Study ID Numbers: 4590
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Vascular Diseases
Cardiovascular Diseases