The primary aim of this study is to study the hemodynamic and pulmonary effects of acute altitude exposure in rest and during exercise in children and adults with complex congenital heart disease. We will compare theire reponses with gender and age…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The hemodynamic and pulmonary effects of acute high altitude exposure. Blood
pressure, heart rate, exercise capacity, saturation, cardiac output, peak O2
uptake en ventilation will be monitored.
Secondary outcome
The association between desaturation and decrease in exercise capacity will be
studied as a secondary objective.
Background summary
Patients with a congenital heart disease have a reduced function of the oxygen
transport system from lung to muscle and organs. During a stay at altitude or
during an airline flight, the barometric pressure is reduced and hence the
partial pressure for oxygen. This could further impede the functioning of the
oxygen transport system because of their limited reserve capacity.
Study objective
The primary aim of this study is to study the hemodynamic and pulmonary
effects of acute altitude exposure in rest and during exercise in children and
adults with complex congenital heart disease. We will compare theire reponses
with gender and age matched apparently healthy peers.
It is our hypothesis that children do have a different response compared to
adults and that patients with congenital heart disease will differ from healthy
peers.
Our secondary objective is to study the association between desaturation and
decrease in exercise capacity.
Study design
This is an explorative observational study with non-invasive measurements.
Testing will be performed at the Wilhelmina Children*s Hospital; including,
cardiopulmonary exercise stress testing on a cycle ergometer (duration 10-15
minutes). A second comparable test will be perfomed (maximal 3 months later),
at a simulated altitude of 2500 meter. Differences between sealevel and 2500
meter (children vs. adults and healthy vs cong. heart disease) will be
investigated
Study burden and risks
Risk and burden are minimal.
lundlaan 6 kamer kb.02.056.0
Utrecht 3508 AB
NL
lundlaan 6 kamer kb.02.056.0
Utrecht 3508 AB
NL
Listed location countries
Age
Inclusion criteria
Children and adults with complex congenital heart disease between 8 years and 40 years of age and apparently helathy peers are eligible.
Exclusion criteria
* Unstable cardiac function (hemodynamic instable irregular heart rate and blood pressure)
* Fever
* Mental or physical disabled patients not able to perform an exercise stress test on a cycle ergometer
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 | NL56769.041.16 |