Excitation-contraction and excitation-transcription coupling in atrial fibrillation
| ISRCTN | ISRCTN05515812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05515812 |
| Secondary identifying numbers | MEC 10-2-004 |
- Submission date
- 28/05/2010
- Registration date
- 10/02/2011
- Last edited
- 29/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Benoit-Gilles Kerfant
Scientific
Scientific
Maastricht University
Cardiovascular Research Institute Maastricht (CARIM)
Department of Physiology
Universiteitssingel 50, Room 3.112
PO Box 616
Maastricht
6200 MD
Netherlands
Study information
| Study design | Interventional open study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Calcium role in the excitation-contraction and excitation-transcription coupling processes in human atrial fibrillation |
| Study objectives | 1. Reduction of the action potential duration in atrial fibrillation (AF) alters the intracellular calcium signaling which can be proarrhythmic 2. The alterations in intracellular calcium signaling affect the nuclear calcium signaling which induces the activation of specific calcium-dependent transcription pathways in AF |
| Ethics approval(s) | Medical Ethics Committee of AZM, Maastricht Hospital, pending as of 28/05/2010 |
| Health condition(s) or problem(s) studied | Cardiac atrial fibrillation |
| Intervention | Biopsies of right atrial appendages in patients in SR, with paroxysmal and persistent AF and undergoing for open chest surgery. |
| Intervention type | Other |
| Primary outcome measure | Measured on day of biopsy: 1. To study the intracellular calcium alterations in human paroxysmal and persistent AF and the proarrhythmic effects of these alterations in comparison to SR 2. To study the nuclear calcium signaling in human paroxysmal and persistent AF in comparison to SR 3. To determine the Ca2+-dependent transcription pathways activated in AF and to study the consequences of the inactivation of these pathways on atrial cell electrical properties (i.e. AP, currents) and function (contraction) |
| Secondary outcome measures | Measured on day of biopsy: 1. To determine the type of intracellular Ca2+ signals which can trigger cellular arrhythmias 2. To determine the key elements which play a major role in the activated calcium-dependent transcription pathways for drug targets 3. Long term goals: to restore contraction in AF and to prevent thrombosis |
| Overall study start date | 01/08/2010 |
| Completion date | 31/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 570 |
| Key inclusion criteria | 1. Patients applying to the predefined groups 2. Patients have given written consent 3. Both women and men between 18 years (included) and 70 years (included) old |
| Key exclusion criteria | 1. Patients who are scheduled for re-operation 2. Patients who do not speak/understand Dutch 3. Patients with sick sinus syndrome, atrioventricular (AV)-block or internal pacemaker 4. Patients who are not will-competent |
| Date of first enrolment | 01/08/2010 |
| Date of final enrolment | 31/01/2015 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Maastricht University
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
Maastricht University (Netherlands)
University/education
University/education
Cardiovascular Research Institute Maastricht (CARIM)
Department of Physiology
Universiteitssingel 50, Room 3.112
PO Box 616
Maastricht
6200 MD
Netherlands
| Website | http://www.maastrichtuniversity.nl |
|---|---|
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
Research organisation
Fondation LEDUCQ (France)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Leducq Foundation
- Location
- France
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
29/05/2020: No publications found.
30/05/2019: Internal review.
