Ephrin B1 Regulation in Human Right Appendage

NCT01080781 | Completed

• 1 other identifier: 09 159 02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• Background : Ephrin-B1 is part of the large Eph/Ephrin system which is involved in cell-cell comunication. The role of Ephrin-B1 has scarcely been studied in adulthood. Our team has shown that this protein is expressed in normal heart in mice and humans. In mice with deletion of the gene encoding Ephrin-B1, we have shown progressive development of dilated cardiomyopathy characterized by dramatic disorganization of cardiac tissue architecture and decreased heart rate variability.
• Purpose: Ephrin-B1 protein was recently identified in human heart but its putative role remains unknown. In knockout mice, deletion of efn gene is associated with abnormalities in cardiac architecture linked to defects in cell-cell tight junctions. From a functional point of view, mice develop a dilated cardiomyopathy and exhibit decreased heart rate variability in the frequency domain. The purpose of this study is to assess if Ephrin-B1 expression is regulated in human heart and if expression level correlates with heart rate variability.
• Abstract: Thirty patients suffering from cardiac disease needing surgery will be included and separated in two groups according to pressure levels in right auricle /and or pulmonary artery. Ephrin-B1 expression will be assessed in right appendages at both the transcriptional (quantitative PCR) and protein (Western blot) levels. Furthermore, the putative relationship between Ephrin-B1 expression and heart rate variability (24 hours ECG recordings) will be investigated.

Conditions

Cardiac Diseases

Keywords

Cardiomyopathy; Ephrin-B1 expression; cell-cell junctions; heart rate variability; right appendage

Outcome Measures

Primary Outcomes (1)

• Expression level of gene encoding Ephrin-B1

  Expression level of gene encoding Ephrin-B1 (quantitative PCR normalized against GAPDH gene expression) on human right appendage biopsies

  1 year

Secondary Outcomes (1)

• Expression level of Ephrin B1 protein

  1year

Study Arms (2)

Group 1

normal pressures in right auricle (\<10 mmHg) /and or pulmonary artery (\<35 mmHg)

Group 2

high pressures in right auricle (\> 10 mmHg) /and or pulmonary artery (\>35 mmHg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac diseases, right appendage

You may qualify if:

• Stable medications for at least 4 weeks

You may not qualify if:

• Patient with pace-maker or atrial fibrillation

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University Hospital

Toulouse, 31000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

right appendage

MeSH Terms

Conditions

Heart Diseases; Cardiomyopathies

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Jean-Michel Senard, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

FR (1)