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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

March 2, 2010
January 22, 2013
March 2010
July 2012   (final data collection date for primary outcome measure)
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
Expression level of gene encoding Ephrin-B1 [ Time Frame: 18 month ] [ Designated as safety issue: No ]
Expression level of gene encoding Ephrin-B1 (quantitative PCR normalized against GAPDH gene expression) on human right appendage biopsies
Complete list of historical versions of study NCT01080781 on ClinicalTrials.gov Archive Site
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
Expression level of Ephrin B1 protein [ Time Frame: 18 month ] [ 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
Not Provided
Not Provided
 
Ephrin B1 Regulation in Human Right Appendage
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.
  • 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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

right appendage

Non-Probability Sample

Cardiac diseases, right appendage

Cardiac Diseases
Not Provided
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01080781
09 159 02
No
University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Jean-Michel Senard, PhD University Hospital, Toulouse
University Hospital, Toulouse
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP