Ephrin B1 Regulation in Human Right Appendage

* 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Diseases Cardiomyopathies Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toulouse University Hospital

Toulouse, 31000, France

About this study

Outcomes
Primary: Expression level of gene encoding Ephrin B1 (quantitative PCR normalized against GAPDH gene expression) on human right appendage biopsies
Secondary: a/ Expression level of Ephrin B1 protein on human right appendage using Western blot and b/ Heart rate variability in both time and spectral domains
Study design: Exploratory, monocentric , prospective and comparative. Two groups of 15 patients each, age and sex matched, with or without elevated pressures in right auricles or pulmonary arteries will be included.
Eligibility criteria:

Inclusion criteria: patients needing cardiac surgery and who had both right catheterism and 24 hours ECG recording before inclusion; stable medications for at least 4 weeks; age > 18 years.
Exclusion criteria: Patient with pace-maker or atrial fibrillation
Number of subjects: 30 patients in two groups of 15 patients each.
Statistical analysis: Qualitative and quantitative variables will be compared using McNemar test and t test respectively. A p value < 0.05 will be considered as significant.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients needing cardiac surgery and who had both right cardiac catheterism and 24 hours ECG recording before inclusion
Stable medications for at least 4 weeks

Exclusion criteria

Patient with pace-maker or atrial fibrillation

Treatment and study plan

Primary outcomes

Expression level of gene encoding Ephrin-B1

Time frame: 1 year

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

Secondary outcomes

Expression level of Ephrin B1 protein

Time frame: 1year

Expression level of Ephrin B1 protein on human right appendage using Western blot and b/ Heart rate variability in both time and spectral domains

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: REBORD

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Mar 4, 2010
Registry last updated: Jan 24, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed