Fontan PalliationNCT00633815
Upright Versus Supine Exercise Testing in Fontan-palliated Patients
An observational study of Fontan Palliation, run by University of Michigan at 1 site in United States.
Trial summary
Fontan-palliated patients comprise an interesting group of single-ventricle patients who are dependent upon passive return of blood from the body to the lungs. Systemic venous pressures are therefore quite elevated, and one study demonstrated that venous capacitance was diminished. Read more about this study
- Who is it for?
- Ages 8 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Fontan Palliation
- What is being tested?
- Supine positioning and Upright positioning
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Nov 2008
- Phase
- Observational
- 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 8 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Fontan-palliated patients aged 8-30 will be recruited for this study. Eligible patients will be identified from the cardiology and surgery database here. Patients will be contacted by phone and/or formal letter informing them of the study. If their primary cardiologist is not in our group, a courtesy call will be made or letter sent. Age and gender matched healthy controls will be sought as well through local recruitment (schools, university campus, local community postings).
Who may be able to join
- S/p Fontan palliation > 2 years prior
- Age 8 to 30 years
Who cannot join
- Pacemaker dependence
- Severe hypoxemia (O2 saturation <80%)
- Recent atrial flutter or other arrhythmias
- Protein losing enteropathy (PLE)
- Severe atrioventricular valve regurgitation
- History of cardiac arrest
- Significant comorbidities (renal failure, asthma, etc).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health Systems, Pediatric Cardiology
Ann Arbor, Michigan, 48109
About this study
Official title: Study of Upright Versus Supine Exercise Testing in Fontan-palliated Patients, Compared With Healthy Controls, to Evaluate for Postural Effects on Exercise Parameters
Fontan-palliated patients comprise an interesting group of single-ventricle patients who are dependent upon passive return of blood from the body to the lungs. Systemic venous pressures are therefore quite elevated, and one study demonstrated that venous capacitance was diminished. In addition, these patients have markedly diminished aerobic capacity (Max VO2). Although one recent study demonstrated that Fontan patients can increase their Max VO2 through diligent cardiac rehabilitation, their ultimate results were still well below average.
It has previously been described that normal, healthy subjects have decreased exercise performance in a supine vs upright position. However, due to high venous pressures and the need for systemic venous return to overcome gravity in order to perfuse the lungs, one might hypothesize that Fontan patients would have increased exercise performance in a supine vs upright position. The investigators are interested in studying this hypothesis.
- Conditions
- Fontan Palliation
- Being tested
- Supine positioning, Upright positioning
- Keywords
- Supine, Upright
- Medical subject headings
- Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine positioningOther
Subjects underwent exercise testing on a stationary bicycle in the supine position
Upright positioningOther
Subjects underwent exercise testing on a stationary bicycle in the upright position
| Study group | Role | What they receive |
|---|---|---|
| Fontan patients | Subjects will undergo exercise testing in both the supine and upright positions Receives: Other: Supine positioning; Other: Upright positioning | |
| Healthy controls | Subjects will undergo exercise testing in both the supine and upright positions Receives: Other: Supine positioning; Other: Upright positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Watts
Measured: 40 minutes
Secondary outcomes (3)
Peak Oxygen Volume (Peak VO2)
milliliters per kilogram of body weight per minute (ml/kg/min)
Measured: 40 minutes
Peak Heart Rate
beats per minute
Measured: 40 minutes
Peak Pulmonary Artery Pressure
millimeters of mercury (mmHg)
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fontan PalliationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Goldstein, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633815
- Sponsor's protocol ID
- HUM00007190
- Status last verified
- May 2017
- First submitted
- 4 Mar 2008
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goldstein BH, Connor CE, Gooding L, Rocchini AP. Relation of systemic venous return, pulmonary vascular resistance, and diastolic dysfunction to exercise capacity in patients with single ventricle receiving fontan palliation. Am J Cardiol. 2010 Apr 15;105(8):1169-75. doi: 10.1016/j.amjcard.2009.12.020. Epub 2010 Feb 20.
PubMed 20381672
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Upright Versus Supine Exercise Testing in Fontan-palliated Patients, Compared With Healthy Controls, to Evaluate for Postural Effects on Exercise Parameters
- ClinicalTrials.gov ID
- NCT00633815
- Acronym / sponsor ID
- HUM00007190
- Conditions
- Fontan Palliation
- Keywords
- Supine, Upright
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Mar 2008 (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.
Fontan-palliated patients comprise an interesting group of single-ventricle patients who are dependent upon passive return of blood from the body to the lungs. Systemic venous pressures are therefore quite elevated, and one study demonstrated that venous capacitance was diminished. In addition, these patients have markedly diminished aerobic capacity (Max VO2). Although one recent study demonstrated that Fontan patients can increase their Max VO2 through diligent cardiac rehabilitation, their ultimate results were still well below average.
It has previously been described that normal, healthy subjects have decreased exercise performance in a supine vs upright position. However, due to high venous pressures and the need for systemic venous return to overcome gravity in order to perfuse the lungs, one might hypothesize that Fontan patients would have increased exercise performance in a supine vs upright position. The investigators are interested in studying this hypothesis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fontan patients | – | Other: Supine positioning, Other: Upright positioningSubjects will undergo exercise testing in both the supine and upright positions |
| Healthy controls | – | Other: Supine positioning, Other: Upright positioningSubjects will undergo exercise testing in both the supine and upright positions |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Fontan-palliated patients aged 8-30 will be recruited for this study. Eligible patients will be identified from the cardiology and surgery database here. Patients will be contacted by phone and/or formal letter informing them of the study. If their primary cardiologist is not in our group, a courtesy call will be made or letter sent. Age and gender matched healthy controls will be sought as well through local recruitment (schools, university campus, local community postings).
Key inclusion criteria (2 listed)
- S/p Fontan palliation > 2 years prior
- Age 8 to 30 years
Key exclusion criteria (7 listed)
- Pacemaker dependence
- Severe hypoxemia (O2 saturation <80%)
- Recent atrial flutter or other arrhythmias
- Protein losing enteropathy (PLE)
- Severe atrioventricular valve regurgitation
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 |
|---|---|---|
| Supine positioningSubjects underwent exercise testing on a stationary bicycle in the supine position | Other | Fontan patients, Healthy controls |
| Upright positioningSubjects underwent exercise testing on a stationary bicycle in the upright position | Other | Fontan patients, Healthy controls |
Primary outcome
Exercise Capacity
Time frame: 40 minutes
Watts
3 secondary outcomes
Peak Oxygen Volume (Peak VO2)
Time frame: 40 minutes
Peak Heart Rate
Time frame: 40 minutes
Peak Pulmonary Artery Pressure
Time frame: 40 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 10 May 2017.
- Results publication: PubMed 20381672Goldstein BH, Connor CE, Gooding L, Rocchini AP. Relation of systemic venous return, pulmonary vascular resistance, and diastolic dysfunction to exercise capacity in patients with single ventricle receiving fontan palliation. Am J Cardiol. 2010 Apr 15;105(8):1169-75. doi: 10.1016/j.amjcard.2009.12.020. Epub 2010 Feb 20.
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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?
An observational study of Fontan Palliation, run by University of Michigan at 1 site in United States.
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 2 inclusion and 7 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 10 May 2017. 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 United States. 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?
Exercise Capacity (time frame: 40 minutes). 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 NCT00633815, which also lists 1 linked publication.
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 10 May 2017.