Studies of Neuregulin/ERBB Signaling in Human Heart

Recruiting

• Conditions: Vascular Disease; Heart Disease; Heart Failure

• Registration Number: NCT02820233
• Lead Sponsor: Douglas B. Sawyer

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2028-09
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of highly proliferative clones isolated	up to 14 days from isolation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maine Medical Center; 🇺🇸 Portland, Maine, United States