Status:
COMPLETED
Cardiopulmonary Adaptation of Short Term Exposure to High Altitude in Fontan Patients: Swiss Fontan & ALtitude COllaboratioN (FALCON) Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Mach Gaensslen Foundation
Conditions:
Fontan Procedure
Altitude
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Important advances in cardiac surgery, intensive care, and diagnostic modalities over the last decades have led to a steady growth in the number of adults with congenital heart defects. Among adults w...
Detailed Description
Background: Important advances in cardiac surgery, intensive care, and diagnostic modalities over the last decades have led to a steady growth in the number of adults with congenital heart defects (G...
Eligibility Criteria
Inclusion
- Age above 18years
- Congenital heart disease and Fontan circulation
- NYHA functional class I \& II
- Peak VO2 \> 45% of predicted
- Signed informed consent
Exclusion
- "Failing Fontan", peak VO2 \< 45% of predicted
- Significant right-to-left shunt
- Baseline arterial O2 saturation at rest \<90% at room air
- Hospitalization within the last 3 months for cardiac reasons
- Decrease in functional NYHA class within the last 3 months
- Motor skill inability to perform a maximal exercise stress test
- Respiratory Exchange Ratio \< 1
- Pregnancy
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT02237274
Start Date
July 1 2014
End Date
December 1 2014
Last Update
February 23 2015
Active Locations (1)
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1
Department of Cardiology, GUCH, Bern University Hospital
Bern, Switzerland, 3010