Studies of Neuregulin/ERBB Signaling in Human Heart

Isolation and Characterization of ERBB Expressing Human Heart Progenitor Cells

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02820233

Enrollment

Registered

2016-06-30

Start date

2015-06-30

Completion date

2029-06-30

Last updated

2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease, Heart Failure, Vascular Disease

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The number of highly proliferative clones isolated	up to 14 days from isolation

Secondary

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

Countries

United States

Contacts

Primary ContactJoanne Burgess, RN

burgejs@mmc.org

Outcome results