Studies of Neuregulin/ERBB Signaling in Human Heart

Heart Failure Clinical Trial

Official title:

Isolation and Characterization of ERBB Expressing Human Heart Progenitor Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02820233
• Other study ID #: 4590
• Status: Recruiting
• Start date: June 2015
• Est. completion date: June 2025

Study information

• Verified date: November 2022
• Source: MaineHealth
• Contact: Joanne Burgess, RN
• Email: burgejs[@]mmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases
• Heart Failure
• Vascular Disease
• Vascular Diseases

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Douglas B. Sawyer	MaineHealth

Country where clinical trial is conducted

United States, 

References & Publications (2)

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;251:28 — View Citation

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 Card — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of highly proliferative clones isolated		up to 14 days from isolation
Secondary	Flow cytometric ERBB receptor expression in highly proliferative clones isolated from heart tissue		up to 14 days from isolation