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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01734356
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 3
• Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2011
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Outcome Measures

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

Criteria

• Ages Eligible for Study: 22 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Nantes University Hospital	Nantes		France

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Vincent PROBST, Nantes UH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT01734356
• Other Study ID Numbers: BRD/10/11-P
• First Posted: Nov 27, 2012
• Last Update Posted: Nov 7, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Nantes University Hospital: iPS; fibroblast; arrhythmias; valvulopathies; electrophysiology; genetics
• Additional relevant MeSH terms: Arrhythmias, Cardiac; Heart Valve Diseases

Study Results

No Results Posted as of Nov 7, 2014