Producing heart cells from patients with inherited heart rhythm disorders from skin cells in order to develop new treatments
| ISRCTN | ISRCTN25297151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25297151 |
| Secondary identifying numbers | V1; 09/02/2015 |
- Submission date
- 04/02/2015
- Registration date
- 13/02/2015
- Last edited
- 03/08/2018
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Inherited Arrhythmia Syndromes (IAS) are caused by changes (mutations) in the genetic make-up of the heart (genes form the pattern of molecules within cells that are inherited from our parents). Heart cells are electrically charged, like a battery so any changes in the make-up of the cell (gene mutations) can cause disruptions to the rhythm of the heart. The heart beat can become irregular (arrhythmia) and sometimes it can stop completely, leading to death. Studying living heart cells is very difficult but this study hopes to take advantage of a new technique that allows scientists to obtain heart cells from samples of skin taken from patients with IAS. The cells obtained from such samples are similar enough to the cells of the heart muscle it is possible to study to effect of the mutations on the electrical properties of the heart. We can determine the cause of arrhythmias and sudden death and then test new therapies within a laboratory. Ultimately this will increase our understanding of IAS and lead to targeted treatments.
Who can participate?
Adult patient with confirmed diagnosis of inherited condition OR family member of patient with inherited condition
What does the study involve?
Collection of sample tissues.
What are the possible benefits and risks of participating?
The benefit is increased understanding of IAS leading to the development of new treatments. There are no risks, other than slight discomfort associated with obtaining a skin biopsy.
Where is the study run from?
Central Manchester NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
From April 2015 to March 2017
Who is funding the study?
University of Manchester
Who is the main contact?
Dr Luigi Venetucci
luigi.venetucci@manchester.ac.uk
Contact information
Scientific
Institute of Cardiovascular Sciences
University of Manchester
Core Technology Facility
Grafton Street
Manchester
M13 9NT
United Kingdom
| Phone | +44 (0)161 275 1202 |
|---|---|
| luigi.venetucci@manchester.ac.uk |
Study information
| Study design | Prospective tissue sample and data collection |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Tissue sample |
| Study setting(s) | Hospital |
| Study type | Screening |
| Scientific title | Use of cardiac myocytes derived from skin fibroblasts to study patients with Inherited Arrhythmia Syndromes (IAS) |
| Study objectives | Discovery science - no hypothesis |
| Ethics approval(s) | RES Committee North West - Greater Manchester Central, 29/04/2015, ref: 15/NW/0301 |
| Health condition(s) or problem(s) studied | Inherited Arrhthymia Syndromes |
| Intervention | Skin biopsy in order to derive cardiac cells |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Derivation of cardiac myocytes from skin fibroblasts obtained from patients affected by inherited arrhythmia syndromes and their family members. |
| Secondary outcome measures | 1. Identification of new genes in patients with inherited arrhythmia syndromes 2. Testing of new treatment strategies for inherited cardiac conditions |
| Overall study start date | 01/04/2015 |
| Completion date | 30/03/2017 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Confirmed diagnosis of inherited condition OR family member of patient with inherited condition 2. Aged > 18 3. Informed consent available |
| Key exclusion criteria | 1. Unwilling or unable to give informed consent 2. Age <18 |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 30/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Grafton Street
Manchester
M13 9WL
United Kingdom
Sponsor information
University/education
3.53 Simon Building
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 275 8795 |
|---|---|
| fmhsethics@manchester.ac.uk | |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- The University of Manchester, University of Manchester UK, University of Manchester in United Kingdom, UoM
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plan to publish in high impact peer-reviewed journals of Cardiology but this is unlikely to be before 2017. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
03/08/2018: This trial did not commence due to a change in study personnel making it impossible to conduct this trial.
24/03/2016: Ethics approval information added.
