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

Fontan Procedure Clinical Trial

— FALCON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237274
• Other study ID #: 222/13
• Status: Completed
• Phase: N/A
• First received: August 26, 2014
• Last updated: February 20, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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 with congenital heart disease, patients with a Fontan circulation typically show the lowest values of peak oxygen consumption. For these patients, strict exclusion from activities at high altitude may have an impact on quality of life. The investigators aim to elucidate the short term effects of a stay at high altitude on hemodynamic adaptation, exercise capacity and clinical well being in adult Fontan patients. The investigators hypothesize that patients with a Fontan circulation in NYHA functional class I-II are able to increase their cardiac output during exercise at high altitude in order to meet the required metabolic demands and therefore tolerate the journey to the Jungfraujoch well.

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 (Grown-up congenital heart disease GUCH). Among adults with congenital heart disease, patients with a Fontan circulation typically show the lowest values of peak oxygen consumption with peak VO2 values between 15 and 29 ml/kg/min, corresponding to 43-64 % of the predicted values in healthy controls. For these patients, strict exclusion from activities at high altitude may have an impact on quality of life. Unfortunately, the most recent recommendations for physical activity, recreation sport, and exercise training in paediatric patients with congenital heart disease do not provide specific recommendations. The investigators study therefore aims to elucidate the short term effects of a stay at high altitude on hemodynamic adaptation, exercise capacity and clinical well being in adult Fontan patients. These results are necessary to counsel GUCH patients with respect to their leasure activities in Switzerland.

Objective:

The aims of the study are to measure a)the hemodynamic adaptation (pulmonary blood flow) at rest and during exercise; b)the response of cardiopulmonary parameters to exercise (ventilation, O2 uptake) and c) heart rate variability and occurrence of arrhythmias during the journey and while performing study measures in patients with a Fontan circulation. The measurements will be performed at high altitude and at lowland and compared with an age- and gender-matched control group of healthy subjects. The objective is to test the clinical tolerance of high altitude exposure after a rapid ascent with public transport in patients with a Fontan circulation. The investigators hypothesize that patients with a Fontan circulation in NYHA functional class I-II are able to increase their cardiac output during exercise at high altitude in order to meet the required metabolic demands despite hypoxia induced pulmonary vasoconstriction and therefore tolerate the journey to the Jungfraujoch well.

Methods:

The investigators aim to include 30 patients with a Fontan circulation and 30 age and gender-matched healthy adults. Baseline testing in Bern (540m over sea level)includes: a symptom limited cardiopulmonary exercise stress test on a cycle ergometer with a ramp protocol (CPX); a pulmonary function test (spirometry); a symptom limited, stepwise increasing workload test with non-invasive inert gas rebreathing method for pulmonary blood flow measurement during exercise (Innocor®); analysis of heart rate variability (HRV); Holter-ECG monitoring for detection of arrhythmias.

Within a time period of 12 weeks, the baseline tests will be repeated on the Jungfraujoch (3454m).

The primary endpoint of this study is the increase of pulmonary blood flow during exercise in response to high altitude exposure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age above 18years

• Congenital heart disease and Fontan circulation

• NYHA functional class I & II

• Peak VO2 > 45% of predicted

• Signed informed consent

Exclusion Criteria:

• "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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Altitude
• Fontan Procedure

Intervention

Other:
• High altitude exposition
High altitude exposition

Locations

Country	Name	City	State
Switzerland	Department of Cardiology, GUCH, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Mach Gaensslen Foundation

Country where clinical trial is conducted

Switzerland, 

References & Publications (7)

Bärtsch P, Gibbs JS. Effect of altitude on the heart and the lungs. Circulation. 2007 Nov 6;116(19):2191-202. Review. — View Citation

Driscoll DJ, Durongpisitkul K. Exercise testing after the Fontan operation. Pediatr Cardiol. 1999 Jan-Feb;20(1):57-9; discussion 60. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pulmonary blood flow during exercise at high altitude	Pulmonary blood flow measurement during exercise: a symptom limited, stepwise increasing workload test with non-invasive inert gas rebreathing method for (Innocor®)	During exercise at high altitude, maximum 12 weeks after baseline measurements	Yes
Secondary	Change from baseline in peak VO2 (exercise capacity)	Peak VO2 (exercise capacity): a symptom limited cardiopulmonary exercise stress test on a cycle ergometer with a ramp protocol (CPX)	During exercise at high altitude, maximum 12 weeks after baseline measurements	Yes
Secondary	Change from baseline in clinical symptoms (tolerance of high alt. exposure, funct.l NYHA class, dyspnea Borg scale)		During exercise at high altitude, maximum 12 weeks after baseline measurements	Yes
Secondary	Change from baseline in sympathovagal balance of the autonomic nervous system		During exercise at high altitude, maximum 12 weeks after baseline measurements	Yes
Secondary	Change from baseline in occurrence of arrhythmias	Measured by holter-ECG monitoring	During exercise at high altitude, maximum 12 weeks after baseline measurements	Yes