Excitation-contraction and excitation-transcription coupling in atrial fibrillation

ISRCTN	ISRCTN05515812
DOI	https://doi.org/10.1186/ISRCTN05515812
Protocol serial number	MEC 10-2-004
Sponsor	Maastricht University (Netherlands)
Funder	Fondation LEDUCQ (France)

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

Maastricht University
Cardiovascular Research Institute Maastricht (CARIM)
Department of Physiology
Universiteitssingel 50, Room 3.112
PO Box 616
Maastricht
6200 MD
Netherlands

Study information

Primary study design	Interventional
Study design	Interventional open study
Secondary study design	Non randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	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
Completion date	31/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

29/05/2020: No publications found.
30/05/2019: Internal review.