Eletrophysiology of iPS-derived CardiomyocytesCLUENCT01865981
Investigating Hereditary Cardiac Disease by Reprogramming Skin Cells to Heart Muscle
An observational study of Eletrophysiology of iPS-derived Cardiomyocytes, run by University of Dundee at 1 site in United Kingdom.
Trial summary
Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life threatening conditions affecting otherwise healthy young individuals. Due to the inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells causing the rhythm disturbance can be difficult to study in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eletrophysiology of iPS-derived Cardiomyocytes
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to 1 Jun 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Arrhythmic patients participating in the Familial Arrhythmia Network Scotland (FANS)
Who may be able to join
- Clinical features of Brugada Syndrome (ECG findings)
- mutation positive or mutation negative
- Idiopathic ventricular fibrillation
Who cannot join
- not able to give informed consent
- Age less than 18 years
- clinical diagnosis ambiguous
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cellular Reprogramming as a Tool to Characterise the Cellular Electrophysiology of Familial Arrhythmia
Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life threatening conditions affecting otherwise healthy young individuals. Due to the inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells causing the rhythm disturbance can be difficult to study in detail and therefore in many cases remain untreatable. The investigators propose to study heart cell electrical function from such patients by reprogramming skin cells to become stem cells and then differentiating them to heart muscle cells.
The hypothesis of the study is that the differentiated cardiac cells will display electrical abnormalities dependent on the mutation causing the disease. These abnormalities can therefore provide a clue as to the nature of the mutation causing the disease or information about its effective management
- Keywords
- iPS cells, cardiomyocytes, Brugada, Ventricular Fibrillation, electrophysiology
- Medical subject headings
- Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hereditary VF | Patients with hereditary ventricular fibrillation, negative for known mutations | |
| Brugada | Patients suffering from Brugada syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Derivation of iPS cells
Induced pluripotent cells will be derived from all participants in the study. Differences in the efficiency of iPS cell generation from different patients will be recorded, and correlated with disease status and age. iPS cell generation will be confirmed by pluripotency markers (stable endogenous gene expression of Nanog, Oct4, Sox2; colony formation; expression of SSEA4) and ability to differentiate in the absence of self-renewal stimulus (ability to self-renew in the absence of self-renewal stimulus -loss of markers above)
Measured: 12 months
Secondary outcomes (2)
Differentiation of iPS cells to cardiomyocytes
The ability of each iPS cell line to differentiate into spontaneously beating cardiomyocytes will be assessed. Efficiency of differentiation per lina and per patient will be recorded.
Measured: 12 months
Electrophysiology on iPS-derived cardiomyocytes
Ability to collect electrophysiological measurements from iPS-derived cardiomyocytes will be asssessed. Resting membrane potential, Ca2+, K+ current function and sponteneous and induced depolarisation will be measured per line and per patient. Correlations with patient disease phenotype will be recorded.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJun 2013
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eletrophysiology of iPS-derived CardiomyocytesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marios P Stavridis, PhD, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865981
- Sponsor's protocol ID
- 2012CA04
- Other IDs
- T13/21
- Acronym
- CLUE
- Status last verified
- Jul 2020
- First submitted
- 15 May 2013
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Reprogramming as a Tool to Characterise the Cellular Electrophysiology of Familial Arrhythmia
- ClinicalTrials.gov ID
- NCT01865981
- Acronym / sponsor ID
- CLUE / 2012CA04
- Keywords
- iPS cells, cardiomyocytes, Brugada, Ventricular Fibrillation, electrophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 31 May 2013 (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.
Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life threatening conditions affecting otherwise healthy young individuals. Due to the inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells causing the rhythm disturbance can be difficult to study in detail and therefore in many cases remain untreatable. The investigators propose to study heart cell electrical function from such patients by reprogramming skin cells to become stem cells and then differentiating them to heart muscle cells.
The hypothesis of the study is that the differentiated cardiac cells will display electrical abnormalities dependent on the mutation causing the disease. These abnormalities can therefore provide a clue as to the nature of the mutation causing the disease or information about its effective management
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hereditary VF | – | –Patients with hereditary ventricular fibrillation, negative for known mutations |
| Brugada | – | –Patients suffering from Brugada syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Arrhythmic patients participating in the Familial Arrhythmia Network Scotland (FANS)
Key inclusion criteria (3 listed)
- Clinical features of Brugada Syndrome (ECG findings)
- mutation positive or mutation negative
- Idiopathic ventricular fibrillation
Key exclusion criteria (3 listed)
- not able to give informed consent
- Age less than 18 years
- clinical diagnosis ambiguous
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Derivation of iPS cells
Time frame: 12 months
Induced pluripotent cells will be derived from all participants in the study. Differences in the efficiency of iPS cell generation from different patients will be recorded, and correlated with disease status and age. iPS cell generation will be confirmed by pluripotency markers (stable endogenous gene expression of Nanog, Oct4, Sox2; colony formation; expression of SSEA4) and ability to differentiate in the absence of self-renewal stimulus (ability to self-renew in the absence of self-renewal stimulus -loss of markers above)
2 secondary outcomes
Differentiation of iPS cells to cardiomyocytes
Time frame: 12 months
Electrophysiology on iPS-derived cardiomyocytes
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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.
Marios P Stavridis, PhD principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eletrophysiology of iPS-derived Cardiomyocytes, run by University of Dundee at 1 site in United Kingdom.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Jul 2020. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Derivation of iPS cells (time frame: 12 months). 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 Jul 2020.