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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734356
First Posted: November 27, 2012
Last Update Posted: November 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
  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: None (Open Label)
Official Title: Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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

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

Estimated Enrollment: 20
Study Start Date: November 2011
Study Completion Date: November 2014
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

Information from the National Library of Medicine

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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
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
France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Vincent PROBST Nantes UH
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01734356     History of Changes
Other Study ID Numbers: BRD/10/11-P
First Submitted: November 22, 2012
First Posted: November 27, 2012
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:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases