Studies of Neuregulin/ERBB Signaling in Human Heart

NCT ID: NCT02820233

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Disease Vascular Disease Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MaineHealth

OTHER

Sponsor Role collaborator

Douglas B. Sawyer

OTHER

Sponsor Role lead

Responsible Party

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Douglas B. Sawyer

Chief Academic Officer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Maine Medical Center

Portland, Maine, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joanne Burgess, RN

Role: CONTACT

Facility Contacts

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Joanne Burgess, RN

Role: primary

207-662-2414

References

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Ryzhov S, Robich MP, Roberts DJ, Favreau-Lessard AJ, Peterson SM, Jachimowicz E, Rath R, Vary CPH, Quinn R, Kramer RS, Sawyer DB. ErbB2 promotes endothelial phenotype of human left ventricular epicardial highly proliferative cells (eHiPC). J Mol Cell Cardiol. 2018 Feb;115:39-50. doi: 10.1016/j.yjmcc.2017.12.013. Epub 2017 Dec 29.

Reference Type BACKGROUND
PMID: 29291395 (View on PubMed)

Robich M, Ryzhov S, Kacer D, Palmeri M, Peterson SM, Quinn RD, Carter D, Sheppard F, Hayes T, Sawyer DB, Rappold J, Prudovsky I, Kramer RS. Prolonged Cardiopulmonary Bypass is Associated With Endothelial Glycocalyx Degradation. J Surg Res. 2020 Jul;251:287-295. doi: 10.1016/j.jss.2020.02.011. Epub 2020 Apr 30.

Reference Type BACKGROUND
PMID: 32199337 (View on PubMed)

de Kay JT, Carver J, Shevenell B, Kosta AM, Tsibulnikov S, Certo E, Sawyer DB, Ryzhov S, Robich MP. Decreased expression of ErbB2 on left ventricular epicardial cells in patients with diabetes mellitus. Cell Signal. 2022 Aug;96:110360. doi: 10.1016/j.cellsig.2022.110360. Epub 2022 May 21.

Reference Type BACKGROUND
PMID: 35609807 (View on PubMed)

Other Identifiers

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4590

Identifier Type: -

Identifier Source: org_study_id

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