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Ephrin B1 Regulation in Human Right Appendage (REBORD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01080781
First received: March 2, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose
  • 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.

Condition
Cardiac Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ephrin B1 Regulation in Human Right Appendage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Expression level of gene encoding Ephrin-B1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Expression level of gene encoding Ephrin-B1 (quantitative PCR normalized against GAPDH gene expression) on human right appendage biopsies


Secondary Outcome Measures:
  • Expression level of Ephrin B1 protein [ Time Frame: 1year ] [ Designated as safety issue: No ]
    Expression level of Ephrin B1 protein on human right appendage using Western blot and b/ Heart rate variability in both time and spectral domains


Biospecimen Retention:   Samples With DNA

right appendage


Enrollment: 30
Study Start Date: March 2010
Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cardiac diseases, right appendage

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080781

Locations
France
Toulouse University Hospital
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Jean-Michel Senard, PhD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01080781     History of Changes
Other Study ID Numbers: 09 159 02
Study First Received: March 2, 2010
Last Updated: January 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Cardiomyopathy
Ephrin-B1 expression
cell-cell junctions
heart rate variability
right appendage

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013