Cardiac DiseasesREBORDNCT01080781
Ephrin B1 Regulation in Human Right Appendage
An observational study of Cardiac Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Diseases
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac diseases, right appendage
Who may be able to join
- 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
Who cannot join
- Patient with pace-maker or atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
Read the 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.
- Conditions
- Cardiac Diseases
- Keywords
- Cardiomyopathy, Ephrin-B1 expression, cell-cell junctions, heart rate variability, right appendage
- Medical subject headings
- Heart Diseases, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Expression level of Ephrin B1 protein
Expression level of Ephrin B1 protein on human right appendage using Western blot and b/ Heart rate variability in both time and spectral domains
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Senard, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080781
- Sponsor's protocol ID
- 09 159 02
- Acronym
- REBORD
- Status last verified
- Jan 2013
- First submitted
- 2 Mar 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ephrin B1 Regulation in Human Right Appendage
- ClinicalTrials.gov ID
- NCT01080781
- Acronym / sponsor ID
- REBORD / 09 159 02
- Conditions
- Cardiac Diseases
- Keywords
- Cardiomyopathy, Ephrin-B1 expression, cell-cell junctions, heart rate variability, right appendage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac diseases, right appendage
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patient with pace-maker or atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Expression level of Ephrin B1 protein
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Senard, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Diseases, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression level of gene encoding Ephrin-B1 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.