To evaluate the clinical usefulness of the VU-AMS in pediatric cardiology.To validate and improve the measures of stroke volume from the VU-AMS device in a clinical population. VU-AMS stroke volume measures will be compared with stroke volume…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important study variables are:
Stroke volume (SV): the amount of blood leaving the heart with a single
heartbeat.
Pre Ejection Period (PEP); The time between the onset of the electrical
activation of the ventricles and the mechanical activation of the ventricles
(opening of the aortic valve). This is a measure of sympathetic activity and
contractility of the heart muscle.
Respiratory sinus arrhythmia (RSA); this is a naturally occurring variation in
heart frequency during a breathing cycle. RSA is the difference in time between
the shortest two successive heart beats and the slowest.
Left ventricular enddiastolic volume as measured by echocardiography and MRI
Maximal oxygen consumption as measured by a maximal exercise test
Secondary outcome
None.
Background summary
The VU-AMS (Vrije Universiteit Ambulatory Monitoring System) is developed at
the VU University and is designed to record four different signals: the
electrocardiogram, impedance cardiogram, movement, and hand skin conductance.
Until today, this device is mainly used to study stress and emotion, both in
laboratory and naturalistic environments. The current study is designed to
evaluate the clinical usefulness of the VU-AMS device in pediatric cardiology.
Daily variations in stroke volume and cardiac autonomic nervous activity will
be measurements of interest. These will be compared to values obtained in a
previous study done in a healthy age matched control group.
Detailed echocardiogram, an MRI and exercise testing will be performed and
subsequently, the VU-AMS device will be worn for 24 hours. Stroke volume
measures from the VU-AMS device and echocardiography will be compared. Also, 24
hour fluctuations in stroke volume and autonomic nervous activity will be
studied. Changes in autonomic nervous activity will be related to exercise
tolerance
Study objective
To evaluate the clinical usefulness of the VU-AMS in pediatric cardiology.
To validate and improve the measures of stroke volume from the VU-AMS device in
a clinical population. VU-AMS stroke volume measures will be compared with
stroke volume measured by echocardiography.
To compare reference values obtained in a normal population of children for
sympathetic- and parasympathetic nervous indices, and stroke volume changes
during rest and exercise.
To study the relationship between daily variation in autonomic nervous system
and stroke volume indices and exercise capacity.
Study design
The design of the study is observational. 120 children with a congenital heart
disease with an age range of 8-18 years will be recruited from the policlinic.
Detailed echocardiography will be performed, including 2- and 3-dimensional
strain and tissue Doppler imaging, jointly with VU-AMS recording to test the
validity of stroke volume measures by the VU-AMS in this population. An MRI and
a symptom limited exercise testing will be performed. Subsequently, the VU-AMS
device will be used to measure 24 hour fluctuations in cardiac sympathetic- and
parasympathetic nervous activity and stroke volume in all children. An i-pod or
i-phone running a program to keep an electronical diary designed at the VU
University will be used to monitor activities and posture and location during
the 24 hour ambulatory measurement.
In case of abnormal findings for which medical act or adjustment of therapy is
deemed necessary, this will be discussed with parents and child and the doctor
will be informed.
Study burden and risks
All children will undergo echocardiogrphy during a 30-minute period and will
wear the VU-AMS device during 24 hours. During that period there are no
restrictions except from bathing and swimming. A cardiac MRI will be performed
and a symptom limited exercise test will be performed as well.
There are no risks in these examinations. Echocardiography, MRI and exercise
testing are part of standard follow-up in these patient groups.
There is a huge amount of experience with the above mentioned evaluations in
children. Usually there are no problems in performing these studies.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Patients after repair of a ventricular septal defect (VSD), patients after coarctectomy, patients after arterial switch operation for transposition of the great arteries, patients with a univentricular heart after Fontan completion.
Exclusion criteria
Comorbidity
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47467.058.14 |