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

This study is currently recruiting participants.
Verified February 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01734356
First received: November 22, 2012
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Inherited Arrhythmias and Valvulopathies
 Other: Skin biopsies

Study Type: Interventional
Study Design: Masking: Open Label
Official Title: Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells

Resource links provided by NLM:

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   22 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734356

Contacts
Contact: Gildas LOUSSOUARN 02 28 08 01 50 gildas.loussouarn@inserm.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France
Contact: Gildas LOUSSOUARN     02 28 08 01 30     gildas.loussouarn@inserm.fr    
Principal Investigator: Vincent PROBST            
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Vincent PROBST Nantes UH
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01734356     History of Changes
Other Study ID Numbers: BRD/10/11-P
Study First Received: November 22, 2012
Last Updated: February 6, 2013
Health Authority: France : Agence Française de Sécurité Sanitaire des Produits de Santé

Keywords provided by Nantes University Hospital:
iPS
fibroblast
arrhythmias
 valvulopathies
electrophysiology
genetics

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013