NCT02237274 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bärtsch P, Gibbs JS
Effect of altitude on the heart and the lungs. Circulation. 2007 Nov 6;116(19):2191-202. Review.
Driscoll DJ, Durongpisitkul K
Exercise testing after the Fontan operation. Pediatr Cardiol. 1999 Jan-Feb;20(1):57-9; discussion 60. Review.
Fredriksen PM, Veldtman G, Hechter S, Therrien J, Chen A, Warsi MA, Freeman M, Liu P, Siu S, Thaulow E, Webb G
Aerobic capacity in adults with various congenital heart diseases. Am J Cardiol. 2001 Feb 1;87(3):310-4.
Freedom RM, Hamilton R, Yoo SJ, Mikailian H, Benson L, McCrindle B, Justino H, Williams WG
The Fontan procedure: analysis of cohorts and late complications. Cardiol Young. 2000 Oct;10(4):307-31. Review.
Luks AM, Stout K, Swenson ER
Evaluating the safety of high-altitude travel in patients with adult congenital heart disease. Congenit Heart Dis. 2010 May-Jun;5(3):220-32. doi: 10.1111/j.1747-0803.2010.00415.x. Review.
Rimoldi SF, Sartori C, Seiler C, Delacrétaz E, Mattle HP, Scherrer U, Allemann Y
High-altitude exposure in patients with cardiovascular disease: risk assessment and practical recommendations. Prog Cardiovasc Dis. 2010 May-Jun;52(6):512-24. doi: 10.1016/j
Takken T, Giardini A, Reybrouck T, Gewillig M, Hövels-Gürich HH, Longmuir PE, McCrindle BW, Paridon SM, Hager A
Recommendations for physical activity, recreation sport, and exercise training in paediatric patients with congenital heart disease: a report

Cardiopulmonary Adaptation of Short Term Exposure to High Altitude in Fontan Patients: Swiss Fontan & ALtitude COllaboratioN (FALCON) Study

Clinical trial NCT02237274 - References