PatientsFONTANEXNCT04151004
Functional Muscle Characteristics and Cardio-respiratory Interaction in Patients With Fontan Palliation
A study testing Incremental cycling test (ICT), Constant load cycling test (CET) and Incremental respiratory muscle test (IncRMET) in people with Patients, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Congenital heart disease (CHD) is the most common congenital defect, affecting about 1% of newborns. Among adults surviving complex CHD, the cohort of survivors after the Fontan palliation for univentricular physiology is the most rapidly growing. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients
- What is being tested?
- Incremental cycling test (ICT), Constant load cycling test (CET) and Incremental respiratory muscle test (IncRMET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Nov 2019to 1 Jun 2022
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 - 55 years
- Fontan palliation (for Fontan patients)
- NYHA I - III (for Fontan patients)
- Willing to adhere to the study rules
Who cannot join
- NYHA IV (for Fontan patients)
- not being able to perform cycle exercise
- known diaphragmatic paresis
- being pregnant or breast feeding
- Intention to become pregnant during the course of the study
- known or suspected non-compliance, drug or alcohol abuse
Show all 10Show fewer
- Regular intake of medication affecting sleep or the performance of the respiratory, cardiovascular or neuromuscular system (except for Fontan-related medication for patients)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- previous enrolment in current study
- being investigator or his/her family member, employee or another dependent person
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Exercise Physiology Lab, Institute of Human Movement Sciences and Sport, ETH Zurich
Zurich, Canton of Zurich, 8057
About this study
Congenital heart disease (CHD) is the most common congenital defect, affecting about 1% of newborns. Among adults surviving complex CHD, the cohort of survivors after the Fontan palliation for univentricular physiology is the most rapidly growing. Given their unique physiology without a pumping chamber supporting the pulmonary circulation, their exercise capacity as adults is often severely reduced. Therefore, patients with grown-up CHD typically need long-term expert medical care causing constantly increasing healthcare- related costs. Specific exercise regimes might offer a safe, efficacious and cost-effective alternative to pharmacologic interventions and surgery. The underlying mechanisms of impaired exercise capacity in Fontan patients are, however, not fully understood and consequently, training regimes specifically tackling the limiting factors cannot be developed. In patients with CHD, studies have suggested that exercise limitations are secondary to the cardiac defects, factors related to cardiac surgery, chronotropic incompetence and underlying lung disease. Similar to heart failure patients, exercise limitations could be traced back to insufficient respiratory and leg muscle functions and impaired cardiovascular regeneration processes possibly due to an altered stem cell number and function in the peripheral blood.
The present study will investigate cardiac, respiratory and quadriceps muscle function at rest and during submaximal and maximal whole-body exercises. A special focus will be given on respiratory and quadriceps muscle strength, and proneness of these muscles to fatigue, which has not yet been objectively investigated. Moreover, different respiratory muscle training (RMT) protocols will be executed, to assess the safety of these interventions. Moreover, the current study will be the first to investigate the influence of exhaustive exercise protocols on the number and function of circulating stem and progenitor cells (CPCs) in Fontan patients. The number of these cell populations was shown to strongly correlate with long-term outcome and recovery in several diseases. This study aims to reveal whether Fontan patients show similarly alternated stem cell number and function in the peripheral blood, that likely result in impaired vascular regeneration processes and possibly also contribute to reduced exercise capacity.
- Conditions
- Patients
- Being tested
- Incremental cycling test (ICT), Constant load cycling test (CET), Incremental respiratory muscle test (IncRMET), Incremental quadriceps muscle test (IncQMT), Respiratory muscle training like interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental cycling test (ICT)Other
Incremental cycling test to volitional exhaustion
Constant load cycling test (CET)Other
Constant load cycling test to volitional exhaustion.
Incremental respiratory muscle test (IncRMET)Other
Incremental respiratory muscle test to volitional exhaustion.
Incremental quadriceps muscle test (IncQMT)Other
Incremental quadriceps muscle test to volitional exhaustion.
Respiratory muscle training like interventionsOther
Three different respiratory muscle training like interventions that are usually used for respiratory muscle trainings.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | Incremental cycling test to volitional exhaustion. Constant load cycling test to volitional exhaustion. Respiratory and leg muscle endurance test to volitional exhaustion. Three respiratory muscle training interventions. Receives: Other: Incremental cycling test (ICT); Other: Constant load cycling test (CET); Other: Incremental respiratory muscle test (IncRMET); Other: Incremental quadriceps muscle test (IncQMT); Other: Respiratory muscle training like interventions |
| Control group | Active comparator | The control group executes the same tests as the patient group. Receives: Other: Incremental cycling test (ICT); Other: Constant load cycling test (CET); Other: Incremental respiratory muscle test (IncRMET); Other: Incremental quadriceps muscle test (IncQMT); Other: Respiratory muscle training like interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory muscle strength (in cmH2O)
Change in respiratory muscle strength will be measured between baseline and after an acute exercise
Measured: At baseline and after acute exercise (approximately 15 minutes)
Change in quadriceps muscle strength (in Newton)
Change in quadriceps muscle strength will be measured between baseline and after an acute exercise
Measured: At baseline and after acute exercise (approximately 15 minutes)
Secondary outcomes (6)
Change in ventilation (in liter per minute)
Change in ventilation will be measured between baseline and after an acute exercise
Measured: On visit 1at baseline and after acute exercise (approximately 15 minutes)
Change in gas exchange (in liter per minute)
Change in gas exchange will be measured between baseline and after an acute exercise
Measured: At baseline and after acute exercise (approximately 15 minutes)
Change in heart rate (beats per minute)
Change in heart rate will be measured between baseline and after an acute exercise
Measured: At baseline and after acute exercise (approximately 15 minutes)
Change in cardiac output (in liter per minute)
Change in cardiac output will be measured between baseline and after an acute exercise
Measured: At baseline and after acute exercise (approximately 15 minutes)
Change in blood pressure (in mmHg)
Change in cardiac output will be measured between baseline and after an acute exercise
Measured: At baseline and after acute exercise (approximately 15 minutes)
Change in blood oxygen saturation (in %)
Change in blood oxygen saturation will be measured between baseline and after an acute exercise
Measured: At baseline and after acute exercise (approximately 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start4 Nov 2019
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PatientsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151004
- Sponsor's protocol ID
- FONTANEX_2019
- Acronym
- FONTANEX
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2019
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Muscle Characteristics and Cardio-respiratory Interaction in Patients With Fontan Palliation
- ClinicalTrials.gov ID
- NCT04151004
- Acronym / sponsor ID
- FONTANEX / FONTANEX_2019
- Conditions
- Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 5 Nov 2019 (actual)
- 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.
Congenital heart disease (CHD) is the most common congenital defect, affecting about 1% of newborns. Among adults surviving complex CHD, the cohort of survivors after the Fontan palliation for univentricular physiology is the most rapidly growing. Given their unique physiology without a pumping chamber supporting the pulmonary circulation, their exercise capacity as adults is often severely reduced. Therefore, patients with grown-up CHD typically need long-term expert medical care causing constantly increasing healthcare- related costs. Specific exercise regimes might offer a safe, efficacious and cost-effective alternative to pharmacologic interventions and surgery. The underlying mechanisms of impaired exercise capacity in Fontan patients are, however, not fully understood and consequently, training regimes specifically tackling the limiting factors cannot be developed. In patients with CHD, studies have suggested that exercise limitations are secondary to the cardiac defects, factors related to cardiac surgery, chronotropic incompetence and underlying lung disease. Similar to heart failure patients, exercise limitations could be traced back to insufficient respiratory and leg muscle functions and impaired cardiovascular regeneration processes possibly due to an altered stem cell number and function in the peripheral blood.
The present study will investigate cardiac, respiratory and quadriceps muscle function at rest and during submaximal and maximal whole-body exercises. A special focus will be given on respiratory and quadriceps muscle strength, and proneness of these muscles to fatigue, which has not yet been objectively investigated. Moreover, different respiratory muscle training (RMT) protocols will be executed, to assess the safety of these interventions. Moreover, the current study will be the first to investigate the influence of exhaustive exercise protocols on the number and function of circulating stem and progenitor cells (CPCs) in Fontan patients. The number of these cell populations was shown to strongly correlate with long-term outcome and recovery in several diseases. This study aims to reveal whether Fontan patients show similarly alternated stem cell number and function in the peripheral blood, that likely result in impaired vascular regeneration processes and possibly also contribute to reduced exercise capacity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Other: Incremental cycling test (ICT), Other: Constant load cycling test (CET), Other: Incremental respiratory muscle test (IncRMET), Other: Incremental quadriceps muscle test (IncQMT), Other: Respiratory muscle training like interventionsIncremental cycling test to volitional exhaustion. Constant load cycling test to volitional exhaustion. Respiratory and leg muscle endurance test to volitional exhaustion. Three respiratory muscle training interventions. |
| Control group | Active comparator | Other: Incremental cycling test (ICT), Other: Constant load cycling test (CET), Other: Incremental respiratory muscle test (IncRMET), Other: Incremental quadriceps muscle test (IncQMT), Other: Respiratory muscle training like interventionsThe control group executes the same tests as the patient group. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18 - 55 years
- Fontan palliation (for Fontan patients)
- NYHA I - III (for Fontan patients)
- Willing to adhere to the study rules
Key exclusion criteria (10 listed)
- NYHA IV (for Fontan patients)
- not being able to perform cycle exercise
- known diaphragmatic paresis
- being pregnant or breast feeding
- Intention to become pregnant during the course of the study
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 |
|---|---|---|
| Incremental cycling test (ICT)Incremental cycling test to volitional exhaustion | Other | Control group, Patient group |
| Constant load cycling test (CET)Constant load cycling test to volitional exhaustion. | Other | Control group, Patient group |
| Incremental respiratory muscle test (IncRMET)Incremental respiratory muscle test to volitional exhaustion. | Other | Control group, Patient group |
| Incremental quadriceps muscle test (IncQMT)Incremental quadriceps muscle test to volitional exhaustion. | Other | Control group, Patient group |
| Respiratory muscle training like interventionsThree different respiratory muscle training like interventions that are usually used for respiratory muscle trainings. | Other | Control group, Patient group |
Primary outcome
Change in respiratory muscle strength (in cmH2O)
Time frame: At baseline and after acute exercise (approximately 15 minutes)
Change in respiratory muscle strength will be measured between baseline and after an acute exercise
Change in quadriceps muscle strength (in Newton)
Time frame: At baseline and after acute exercise (approximately 15 minutes)
Change in quadriceps muscle strength will be measured between baseline and after an acute exercise
6 secondary outcomes
Change in ventilation (in liter per minute)
Time frame: On visit 1at baseline and after acute exercise (approximately 15 minutes)
Change in gas exchange (in liter per minute)
Time frame: At baseline and after acute exercise (approximately 15 minutes)
Change in heart rate (beats per minute)
Time frame: At baseline and after acute exercise (approximately 15 minutes)
Change in cardiac output (in liter per minute)
Time frame: At baseline and after acute exercise (approximately 15 minutes)
Change in blood pressure (in mmHg)
Time frame: At baseline and after acute exercise (approximately 15 minutes)
Change in blood oxygen saturation (in %)
Time frame: At baseline and after acute exercise (approximately 15 minutes)
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 26 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incremental cycling test (ICT), Constant load cycling test (CET) and Incremental respiratory muscle test (IncRMET) in people with Patients, run by Swiss Federal Institute of Technology 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 4 inclusion and 10 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 26 Oct 2022. 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 in respiratory muscle strength (in cmH2O) (time frame: At baseline and after acute exercise (approximately 15 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2022.