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Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells (Diag-iPS)

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ClinicalTrials.gov Identifier: NCT01734356
Recruitment Status : Terminated
First Posted : November 27, 2012
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief Summary:
The recent developments of research on iPS (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with genetic and cellular characteristics of the donors. These cells represent a biological material more readily available to identify the pathophysiological mechanisms involved in the diseases of BrS or ERS patients, which will lead to the identification of genetic markers.

Condition or disease Intervention/treatment Phase
Inherited Arrhythmias and Valvulopathies Other: Skin biopsies Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Masking: None (Open Label)
Official Title: Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells
Study Start Date : November 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
inherited arrhythmias
6 patient with inherited arrhythmias
 Other: Skin biopsies
valvulopathies
6 patient with valvulopathies
 Other: Skin biopsies
controle
8 healthy people for these pathologies
 Other: Skin biopsies


Outcome Measures
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Primary Outcome Measures :
  1. Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient

Secondary Outcome Measures :
  1. Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy

Eligibility Criteria
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Ages Eligible for Study:   22 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Patient with a family history of inherited arrhythmia or valvulopathy
  • Age : 22-60 yo.
  • patient no confine to bed
  • Male or female
  • Written consent
  • Patient affiliated to the French social security

Exclusion criteria:

  • Pregnant woman
  • Patient under 22 yo or adults under guardianship
  • Indication against local anesthesia
  • Anticoagulant treatment
  • Absence or positivity of HIV, HBV, HCV serology
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734356


Locations
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France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Vincent PROBST Nantes UH
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01734356    
Other Study ID Numbers: BRD/10/11-P
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014
Keywords provided by Nantes University Hospital:
iPS
fibroblast
arrhythmias
 valvulopathies
electrophysiology
genetics
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes