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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Inselspital, Berne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mach Gaensslen Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 222/13

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