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

February 20, 2015 updated by: University Hospital Inselspital, Berne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Cardiology, GUCH, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with Fontan circulation
High altitude exposition
Other: High altitude exposition
High altitude exposition
OTHER: Age and gender-matched healthy volunteers
High altitude exposition
Other: High altitude exposition
High altitude exposition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®)
During exercise at high altitude, maximum 12 weeks after baseline measurements

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in peak VO2 (exercise capacity)
Time Frame: During exercise at high altitude, maximum 12 weeks after baseline measurements
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
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
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
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
Measured by holter-ECG monitoring
During exercise at high altitude, maximum 12 weeks after baseline measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Mach Gaensslen Foundation

Investigators

  • Principal Investigator: Markus Schwerzmann, Professor, Dr med., Department of Cardiology, GUCH, Bern University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (ESTIMATE)

September 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 222/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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