NCT02237274

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

August 26, 2014

Last Update Submit

February 20, 2015

Conditions

Fontan ProcedureAltitude

Keywords

Fontan circulationHigh altitude exposure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change from baseline in peak VO2 (exercise capacity)

    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)

    During exercise at high altitude, maximum 12 weeks after baseline measurements

  • Change from baseline in sympathovagal balance of the autonomic nervous system

    During exercise at high altitude, maximum 12 weeks after baseline measurements

  • Change from baseline in occurrence of arrhythmias

    During exercise at high altitude, maximum 12 weeks after baseline measurements

Study Arms (2)

Patients with Fontan circulation

EXPERIMENTAL

High altitude exposition

Other: High altitude exposition

Age and gender-matched healthy volunteers

OTHER

High altitude exposition

Other: High altitude exposition

Interventions

High altitude expositionOTHER

High altitude exposition

Age and gender-matched healthy volunteersPatients with Fontan circulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18years
  • Congenital heart disease and Fontan circulation
  • NYHA functional class I \& II
  • Peak VO2 \> 45% of predicted
  • Signed informed consent

You may not qualify if:

  • "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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, GUCH, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (8)

  • 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.

    PMID: 17984389RESULT

  • 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. doi: 10.1016/s0002-9149(00)01364-3.

    PMID: 11165966RESULT

  • Driscoll 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.

    PMID: 9861079RESULT

  • 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. doi: 10.1017/s1047951100009616. No abstract available.

    PMID: 10950328RESULT

  • Takken 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.

    PMID: 23126001RESULT

  • Rimoldi 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.

    PMID: 20417345RESULT

  • 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.

    PMID: 20576041RESULT

  • Staempfli 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.

    PMID: 27217067DERIVED

Study Officials

  • Markus Schwerzmann, Professor, Dr med.

    Department of Cardiology, GUCH, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

September 11, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

February 23, 2015

Record last verified: 2015-02

Locations

CH(1)