Fontan ProcedureFALCONNCT02237274
Cardiopulmonary Adaptation of Short Term Exposure to High Altitude in Fontan Patients: Swiss Fontan & ALtitude COllaboratioN (FALCON) Study
A study testing High altitude exposition in people with Fontan Procedure and Altitude, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fontan Procedure, Altitude
- What is being tested?
- High altitude exposition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18years
- Congenital heart disease and Fontan circulation
- NYHA functional class I \& II
- Peak VO2 > 45% of predicted
- Signed informed consent
Who cannot join
- "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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Cardiology, GUCH, Bern University Hospital
Bern, 3010
About this study
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.
Read the 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 (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.
- Conditions
- Fontan Procedure, Altitude
- Being tested
- High altitude exposition
- Keywords
- Fontan circulation, High altitude exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High altitude expositionOther
High altitude exposition
| Study group | Role | What they receive |
|---|---|---|
| Patients with Fontan circulation | Experimental | High altitude exposition Receives: Other: High altitude exposition |
| Age and gender-matched healthy volunteers | Other | High altitude exposition Receives: Other: High altitude exposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®)
Measured: During exercise at high altitude, maximum 12 weeks after baseline measurements
Secondary outcomes (4)
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)
Measured: During exercise at high altitude, maximum 12 weeks after baseline measurements
Change from baseline in clinical symptoms (tolerance of high alt. exposure, funct.l NYHA class, dyspnea Borg scale)
Measured: During exercise at high altitude, maximum 12 weeks after baseline measurements
Change from baseline in sympathovagal balance of the autonomic nervous system
Measured: During exercise at high altitude, maximum 12 weeks after baseline measurements
Change from baseline in occurrence of arrhythmias
Measured by holter-ECG monitoring
Measured: During exercise at high altitude, maximum 12 weeks after baseline measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fontan ProcedureStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Mach Gaensslen Foundation
- Responsible party
- Sponsor
- Investigators
- Markus Schwerzmann, Professor, Dr med., Principal investigator, Department of Cardiology, GUCH, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237274
- Sponsor's protocol ID
- 222/13
- Acronym
- FALCON
- Status last verified
- Feb 2015
- First submitted
- 26 Aug 2014
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bartsch P, Gibbs JS. Effect of altitude on the heart and the lungs. Circulation. 2007 Nov 6;116(19):2191-202. doi: 10.1161/CIRCULATIONAHA.106.650796. No abstract available.
PubMed 17984389Fredriksen 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. doi: 10.1016/s0002-9149(00)01364-3.
PubMed 11165966Driscoll DJ, Durongpisitkul K. Exercise testing after the Fontan operation. Pediatr Cardiol. 1999 Jan-Feb;20(1):57-9; discussion 60. doi: 10.1007/s002469900397. No abstract available.
PubMed 9861079Freedom 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. doi: 10.1017/s1047951100009616. No abstract available.
PubMed 10950328Takken T, Giardini A, Reybrouck T, Gewillig M, Hovels-Gurich 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 from the Exercise, Basic & Translational Research Section of the European Association of Cardiovascular Prevention and Rehabilitation, the European Congenital Heart and Lung Exercise Group, and the Association for European Paediatric Cardiology. Eur J Prev Cardiol. 2012 Oct;19(5):1034-65. doi: 10.1177/1741826711420000.
PubMed 23126001Rimoldi SF, Sartori C, Seiler C, Delacretaz 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.pcad.2010.03.005.
PubMed 20417345Luks 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.
PubMed 20576041Staempfli R, Schmid JP, Schenker S, Eser P, Trachsel LD, Deluigi C, Wustmann K, Thomet C, Greutmann M, Tobler D, Stambach D, Wilhelm M, Schwerzmann M. Cardiopulmonary adaptation to short-term high altitude exposure in adult Fontan patients. Heart. 2016 Aug 15;102(16):1296-301. doi: 10.1136/heartjnl-2016-309682. Epub 2016 May 23.
PubMed 27217067
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Adaptation of Short Term Exposure to High Altitude in Fontan Patients: Swiss Fontan & ALtitude COllaboratioN (FALCON) Study
- ClinicalTrials.gov ID
- NCT02237274
- Acronym / sponsor ID
- FALCON / 222/13
- Conditions
- Fontan Procedure, Altitude
- Keywords
- Fontan circulation, High altitude exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Mach Gaensslen Foundation
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Fontan circulation | Experimental | Other: High altitude expositionHigh altitude exposition |
| Age and gender-matched healthy volunteers | Other | Other: High altitude expositionHigh altitude exposition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18years
- Congenital heart disease and Fontan circulation
- NYHA functional class I \& II
- Peak VO2 > 45% of predicted
- Signed informed consent
Key exclusion criteria (8 listed)
- "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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High altitude expositionHigh altitude exposition | Other | Age and gender-matched healthy volunteers, Patients with Fontan circulation |
Primary outcome
Change from baseline in pulmonary blood flow during exercise at high altitude
Time frame: During exercise at high altitude, maximum 12 weeks after baseline measurements
Pulmonary blood flow measurement during exercise: a symptom limited, stepwise increasing workload test with non-invasive inert gas rebreathing method for (Innocor®)
4 secondary outcomes
Change from baseline in peak VO2 (exercise capacity)
Time frame: During exercise at high altitude, maximum 12 weeks after baseline measurements
Change from baseline in clinical symptoms (tolerance of high alt. exposure, funct.l NYHA class, dyspnea Borg scale)
Time frame: During exercise at high altitude, maximum 12 weeks after baseline measurements
Change from baseline in sympathovagal balance of the autonomic nervous system
Time frame: During exercise at high altitude, maximum 12 weeks after baseline measurements
Change from baseline in occurrence of arrhythmias
Time frame: During exercise at high altitude, maximum 12 weeks after baseline measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Results publication: PubMed 17984389Bartsch P, Gibbs JS. Effect of altitude on the heart and the lungs. Circulation. 2007 Nov 6;116(19):2191-202. doi: 10.1161/CIRCULATIONAHA.106.650796. No abstract available.
- Results publication: PubMed 11165966Fredriksen 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. doi: 10.1016/s0002-9149(00)01364-3.
- Results publication: PubMed 9861079Driscoll DJ, Durongpisitkul K. Exercise testing after the Fontan operation. Pediatr Cardiol. 1999 Jan-Feb;20(1):57-9; discussion 60. doi: 10.1007/s002469900397. No abstract available.
- Results publication: PubMed 10950328Freedom 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. doi: 10.1017/s1047951100009616. No abstract available.
- Results publication: PubMed 23126001Takken T, Giardini A, Reybrouck T, Gewillig M, Hovels-Gurich 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 from the Exercise, Basic & Translational Research Section of the European Association of Cardiovascular Prevention and Rehabilitation, the European Congenital Heart and Lung Exercise Group, and the Association for European Paediatric Cardiology. Eur J Prev Cardiol. 2012 Oct;19(5):1034-65. doi: 10.1177/1741826711420000.
- Results publication: PubMed 20417345Rimoldi SF, Sartori C, Seiler C, Delacretaz 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.pcad.2010.03.005.
- Results publication: PubMed 20576041Luks 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.
- Derived from this study: PubMed 27217067Staempfli R, Schmid JP, Schenker S, Eser P, Trachsel LD, Deluigi C, Wustmann K, Thomet C, Greutmann M, Tobler D, Stambach D, Wilhelm M, Schwerzmann M. Cardiopulmonary adaptation to short-term high altitude exposure in adult Fontan patients. Heart. 2016 Aug 15;102(16):1296-301. doi: 10.1136/heartjnl-2016-309682. Epub 2016 May 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Schwerzmann, Professor, Dr med. principal investigator
Department of Cardiology, GUCH, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High altitude exposition in people with Fontan Procedure and Altitude, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pulmonary blood flow during exercise at high altitude (time frame: During exercise at high altitude, maximum 12 weeks after baseline measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02237274, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2015.