Inherited Arrhythmias and ValvulopathiesDiag-iPSNCT01734356
Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells
A study testing Skin biopsies in people with Inherited Arrhythmias and Valvulopathies, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inherited Arrhythmias and Valvulopathies
- What is being tested?
- Skin biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Nov 2014
- Phase
- Interventional
- 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 22 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant woman
- Patient under 22 yo or adults under guardianship
- Indication against local anesthesia
- Anticoagulant treatment
- Absence or positivity of HIV, HBV, HCV serology
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inherited Arrhythmias and Valvulopathies
- Being tested
- Skin biopsies
- Keywords
- iPS, fibroblast, arrhythmias, valvulopathies, electrophysiology, genetics
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsiesOther
| Study group | Role | What they receive |
|---|---|---|
| inherited arrhythmias | Other | 6 patient with inherited arrhythmias Receives: Other: Skin biopsies |
| valvulopathies | Other | 6 patient with valvulopathies Receives: Other: Skin biopsies |
| controle | Other | 8 healthy people for these pathologies Receives: Other: Skin biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient
Secondary outcomes (1)
Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Arrhythmias and ValvulopathiesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent PROBST, Principal investigator, Nantes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734356
- Sponsor's protocol ID
- BRD/10/11-P
- Acronym
- Diag-iPS
- Status last verified
- Nov 2014
- First submitted
- 22 Nov 2012
- Last updated
- 7 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells
- ClinicalTrials.gov ID
- NCT01734356
- Acronym / sponsor ID
- Diag-iPS / BRD/10/11-P
- Conditions
- Inherited Arrhythmias and Valvulopathies
- Keywords
- iPS, fibroblast, arrhythmias, valvulopathies, electrophysiology, genetics
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Nov 2012 (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.
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.
Study design
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| inherited arrhythmias | Other | Other: Skin biopsies6 patient with inherited arrhythmias |
| valvulopathies | Other | Other: Skin biopsies6 patient with valvulopathies |
| controle | Other | Other: Skin biopsies8 healthy people for these pathologies |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient with a family history of inherited arrhythmia or valvulopathy
- Age : 22-60 yo.
- patient no confine to bed
- Male or female
- Written consent
Key exclusion criteria (5 listed)
- Pregnant woman
- Patient under 22 yo or adults under guardianship
- Indication against local anesthesia
- Anticoagulant treatment
- Absence or positivity of HIV, HBV, HCV serology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsies | Other | controle, inherited arrhythmias, valvulopathies |
Primary outcome
Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient
1 secondary outcome
Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
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.
Vincent PROBST principal investigator
Nantes UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsies in people with Inherited Arrhythmias and Valvulopathies, run by Nantes University Hospital 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Nov 2014. 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 was stopped early. Results are not available in the source record.
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?
Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient. 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 7 Nov 2014.