Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC 10-2-004
Study information
Scientific title
Calcium role in the excitation-contraction and excitation-transcription coupling processes in human atrial fibrillation
Acronym
Study hypothesis
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
Medical Ethics Committee of AZM, Maastricht Hospital, pending as of 28/05/2010
Study design
Interventional open study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/08/2010
Overall trial end date
31/01/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
570
Participant 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
Recruitment start date
01/08/2010
Recruitment end date
31/01/2015
Locations
Countries of recruitment
Netherlands
Trial participating centre
Maastricht University
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
Maastricht University (Netherlands)
Sponsor details
Cardiovascular Research Institute Maastricht (CARIM)
Department of Physiology
Universiteitssingel 50
Room 3.112
PO Box 616
Maastricht
6200 MD
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Fondation LEDUCQ (France)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
France
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary