Condition category
Circulatory System
Date applied
28/05/2010
Date assigned
10/02/2011
Last edited
10/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Benoit-Gilles Kerfant

ORCID ID

Contact details

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

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

http://www.maastrichtuniversity.nl

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

Publication citations

Additional files

Editorial Notes