To elucidate the correlation between proteostasis marker levels in serum and atrial tissue, and initiation and progression of AF in patients.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical characteristics and electrophysiological parameters (e.g. pattern of
activation, conduction block, epicardial breakthrough, fibrillation interval)
will be correlated with proteostasis marker levels and atrial tissue
characteristics. Endpoints are postprocedural development or recurrence of AF,
or completion of the five year follow up period.
Secondary outcome
nvt
Background summary
Mechanisms of both electrical and structural underlying atrial fibrillation
(AF) is unclear despite years of intensive research. A potential pathway
leading to structural cell damage might explain the mechanism underlying AF.
This pathway involves activation of proteostasis markers such as heat shock
proteins (HSPs) which have cardioprotective characteristics. Hence, patients
with a lower proteostasis marker level might be more prone to structural tissue
damage and development or recurrence of AF.
Hypothesis: patient with a low baseline proteostasis marker level such as HSPs
are more likely to have atrial electropathology and to develop postprocedural
AF.
Study objective
To elucidate the correlation between proteostasis marker levels in serum and
atrial tissue, and initiation and progression of AF in patients.
Study design
The HALT & REVERSE is a prospective observational study, with a planned
duration of 60 months. Correlation between tissue proteostasis marker levels
(in blood and/or atrial appendages), degree of electropathology and development
of AF will be studied in patients planned for elective open heart surgery, for
elective pulmonary vein isolation (PVI) and patients presenting for electric
cardioversion. Epicardial mapping is performed in patients undergoing cardiac
surgery. Endovascular mapping will be performed in patients scheduled for PVI.
In all patients, proteostasis marker levels will be determined in blood
samples. In addition, in patients undergoing cardiac surgery, a small tissue
sample of the atrial appendages will be analyzed. Post procedural continuous
rhythm monitoring is performed for arrhythmia detection.
Intervention
In patients undergoing cardiac surgery, a mapping procedure is performed, which
includes induction of atrial fibrillation.
Study burden and risks
For participants of this study there aren*t any direct benefits. Neither the
patient, nor the investigators are in any way compensated for their
participation with regards to this study. The risks associated with
participation are known to be negligible, since mapping in over 926 patients
(QUASAR study, n=466; Halt &Reverse study, n=460) did not cause any
complications.
Dr Molewaterplein 40
Rotterdam 3015GD
NL
Dr Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Adult patients (>18 yr), scheduled for cardiac surgery (N=1080), pulmonary vein
isolation (first time and redo procedures N=100), electrical cardioversion
(N=100) or electieve electrophysiological study (controls N=100)
Exclusion criteria
Hemodynamic instability
Usage of inotropic agents
Emergency cardiac surgery
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL49785.078.14 |
| OMON | NL-OMON23418 |