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NCT Number: NCT02820233

Studies of Neuregulin/ERBB Signaling in Human Heart

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maine Medical Center

Portland, Maine, 04102, United States

Location status: Recruiting

Location contact

Joanne Burgess, RN

CONTACT

[email protected]

207-662-2414

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The number of highly proliferative clones isolated

    Time frame: up to 14 days from isolation

Secondary outcomes

  1. Flow cytometric ERBB receptor expression in highly proliferative clones isolated from heart tissue

    Time frame: up to 14 days from isolation

Study contacts

Contact information is provided by the study sponsor or research team.

Joanne Burgess, RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Douglas B. Sawyer

Other

Collaborators

  • MaineHealth

Registry information

Official study title

Isolation and Characterization of ERBB Expressing Human Heart Progenitor Cells

Important dates

Study start
2015
Primary completion
2028
Study completion
2029
First posted
Jun 30, 2016
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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