Fontan PalliationNCT02659462
Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.
An observational study of Fontan Palliation and Congenital Heart Disease, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
prospective cardio respiratory evaluation for patients post the Fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the functional capacity and the primary etiology for reduction in functional capacity. Read more about this study
- Who is it for?
- Ages 8 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Fontan Palliation, Congenital Heart Disease
- What is being tested?
- Cardio Pulmonary Exercise Testing
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Dec 2016
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 1. 15 patients post the Fontal palliation for single ventricular heart 2. 15 subjects post surgical correction of congenital heart disease. 3. 15 healthy subjects.
Who may be able to join
- Children at age of 8-25 post fontan palliation
- Patients With Repaired Congenital Heart Disease without chronic lung disease
- Healthy patients ate age of 8-25
Who cannot join
- Patients with chronic lung disease
- Pregnant women
- Patients with acute active disease or chronic disease that may affect the exercise function
Trial locations and contacts
1 site in 1 country.
About this study
prospective cardio respiratory evaluation for patients post the Fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the functional capacity and the primary etiology for reduction in functional capacity.
- Conditions
- Fontan Palliation, Congenital Heart Disease
- Being tested
- Cardio Pulmonary Exercise Testing
- Keywords
- Repaired Congenital Heart Disease, Cardio Pulmonary Exercise Testing, Fontan, Fontan Palliation, functional capacity
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio Pulmonary Exercise TestingOther
Cardio Pulmonary Exercise Testing
| Study group | Role | What they receive |
|---|---|---|
| patients post Fontan palliation for single ventricular hear | Cardio Pulmonary Exercise Testing Receives: Other: Cardio Pulmonary Exercise Testing | |
| Subjects post surgical correction of congenital heart disease | Cardio Pulmonary Exercise Testing Receives: Other: Cardio Pulmonary Exercise Testing | |
| Healthy patients | Cardio Pulmonary Exercise Testing Receives: Other: Cardio Pulmonary Exercise Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing Cardio Pulmonary Exercise function between the three groups in the study
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fontan PalliationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659462
- Sponsor's protocol ID
- 0124-15-RMB CTIL
- Status last verified
- Jan 2016
- First submitted
- 22 Nov 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rhodes J, Ubeda Tikkanen A, Jenkins KJ. Exercise testing and training in children with congenital heart disease. Circulation. 2010 Nov 9;122(19):1957-67. doi: 10.1161/CIRCULATIONAHA.110.958025. No abstract available.
PubMed 21060085American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02659462
- Acronym / sponsor ID
- 0124-15-RMB CTIL
- Conditions
- Fontan Palliation, Congenital Heart Disease
- Keywords
- Repaired Congenital Heart Disease, Cardio Pulmonary Exercise Testing, Fontan, Fontan Palliation, functional capacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Jan 2016 (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.
prospective cardio respiratory evaluation for patients post the Fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the functional capacity and the primary etiology for reduction in functional capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients post Fontan palliation for single ventricular hear | – | Other: Cardio Pulmonary Exercise TestingCardio Pulmonary Exercise Testing |
| Subjects post surgical correction of congenital heart disease | – | Other: Cardio Pulmonary Exercise TestingCardio Pulmonary Exercise Testing |
| Healthy patients | – | Other: Cardio Pulmonary Exercise TestingCardio Pulmonary Exercise Testing |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 1. 15 patients post the Fontal palliation for single ventricular heart 2. 15 subjects post surgical correction of congenital heart disease. 3. 15 healthy subjects.
Key inclusion criteria (3 listed)
- Children at age of 8-25 post fontan palliation
- Patients With Repaired Congenital Heart Disease without chronic lung disease
- Healthy patients ate age of 8-25
Key exclusion criteria (3 listed)
- Patients with chronic lung disease
- Pregnant women
- Patients with acute active disease or chronic disease that may affect the exercise function
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 |
|---|---|---|
| Cardio Pulmonary Exercise TestingCardio Pulmonary Exercise Testing | Other | Healthy patients, Subjects post surgical correction of congenital heart disease, patients post Fontan palliation for single ventricular hear |
Primary outcome
Comparing Cardio Pulmonary Exercise function between the three groups in the study
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Background: PubMed 21060085Rhodes J, Ubeda Tikkanen A, Jenkins KJ. Exercise testing and training in children with congenital heart disease. Circulation. 2010 Nov 9;122(19):1957-67. doi: 10.1161/CIRCULATIONAHA.110.958025. No abstract available.
- Background: PubMed 12524257American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
Related trials for Fontan Palliation
RecruitingPhase 3
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Fontan Palliation
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 and Congenital Heart Disease, run by Rambam Health Care Campus at 1 site in Israel.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jan 2016. 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 Israel. 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?
Results are not available in the source record.
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?
Comparing Cardio Pulmonary Exercise function between the three groups in the study (time frame: one year). 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 NCT02659462, which also lists 2 linked publications.
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 20 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.