Fontan ProcedureNCT01107990
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
An observational study of Fontan Procedure and Hypoplastic Left Heart Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work. The investigators hypothesize that myocardial strain , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to 20 Sep 2012
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study subjects: Patients with univentricular hearts who have undergone a Fontan procedure will be recruited for participation in the study.
Who may be able to join
- Anatomy: The investigators will enroll 10 patients with single right ventricles status post Fontan and 10 patients with single left ventricles status post Fontan.
- Age range: 5 patients in each group will be between the ages of 10-18 years of age and 5 patients in each group will be older than 18 years of age.
Who cannot join
- Study subjects will be excluded if there are any contraindications to MRI including permanent pacemaker, ICD, retained permanent wires, cerebral aneurysm clips, neurostimulators, insulin or infusion pumps, implanted drug infusion devices, bone growth/fusion stimulators, or cochlear implants.
- In addition, patients with implanted hardware that may lead to inadequate imaging, such as steel coils or ventricular septal defect occluder devices, will be excluded.
- Finally, patients with developmental delay or physical limitations precluding cooperation with the MRI or exercise test or patients with claustrophobia will be excluded. Patients will be asked if there is any chance that they are pregnant. If they are possibly pregnant, they will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San-Francisco
San Francisco, California, 94143
About this study
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work. The investigators hypothesize that myocardial strain , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts. This abnormality is associated with depressed cardiac power output and impaired exercise capacity. The study will utilize cardiac magnetic resonance imaging, exercise testing, and lung function testing to study how the single ventricle heart works so that in the future the investigators can improve how the investigators care for patients with this type of congenital heart disease.
The research protocol involves: Cardiac magnetic resonance imaging (MRI of the heart), exercise tests, and lung function tests. Some of these tests are routinely used to follow patients with single ventricles. Some of these tests are part of the research protocol. If you agree to participate in this study, these tests will be performed at UCSF. The results of the routine tests will be shared with your doctor.
Participation will require approximately 30 additional minutes to the cardiac MRI procedure to collect the research data. The exercise tests, and lung function tests time commitment will take about two hours.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Double Inlet Left Ventricle
- Medical subject headings
- Hypoplastic Left Heart Syndrome, Tricuspid Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single right ventricles | Not described | |
| Single left ventricles | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global and regional myocardial strain (radial, longitudinal and circumferential) as measured by cardiac MRI.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startNov 2009
- Primary completion20 Sep 2012
- Study completion20 Sep 2012
Why it stopped: PI time constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fontan ProcedureStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Lowenthal, MD, Principal investigator, University of California, San FranciscoAlison Meadows, MD, PhD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107990
- Sponsor's protocol ID
- H64391-34645-01
- Status last verified
- Jan 2020
- First submitted
- 20 Apr 2010
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
- ClinicalTrials.gov ID
- NCT01107990
- Acronym / sponsor ID
- H64391-34645-01
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Double Inlet Left Ventricle
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI time constraints
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- 20 Sep 2012 (actual)
- Study completion
- 20 Sep 2012 (actual)
- First posted
- 21 Apr 2010 (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.
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work. The investigators hypothesize that myocardial strain , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts. This abnormality is associated with depressed cardiac power output and impaired exercise capacity. The study will utilize cardiac magnetic resonance imaging, exercise testing, and lung function testing to study how the single ventricle heart works so that in the future the investigators can improve how the investigators care for patients with this type of congenital heart disease.
The research protocol involves: Cardiac magnetic resonance imaging (MRI of the heart), exercise tests, and lung function tests. Some of these tests are routinely used to follow patients with single ventricles. Some of these tests are part of the research protocol. If you agree to participate in this study, these tests will be performed at UCSF. The results of the routine tests will be shared with your doctor.
Participation will require approximately 30 additional minutes to the cardiac MRI procedure to collect the research data. The exercise tests, and lung function tests time commitment will take about two hours.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single right ventricles | – | – |
| Single left ventricles | – | – |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study subjects: Patients with univentricular hearts who have undergone a Fontan procedure will be recruited for participation in the study.
Key inclusion criteria (2 listed)
- Anatomy: The investigators will enroll 10 patients with single right ventricles status post Fontan and 10 patients with single left ventricles status post Fontan.
- Age range: 5 patients in each group will be between the ages of 10-18 years of age and 5 patients in each group will be older than 18 years of age.
Key exclusion criteria (3 listed)
- Study subjects will be excluded if there are any contraindications to MRI including permanent pacemaker, ICD, retained permanent wires, cerebral aneurysm clips, neurostimulators, insulin or infusion pumps, implanted drug infusion devices, bone growth/fusion stimulators, or cochlear implants.
- In addition, patients with implanted hardware that may lead to inadequate imaging, such as steel coils or ventricular septal defect occluder devices, will be excluded.
- Finally, patients with developmental delay or physical limitations precluding cooperation with the MRI or exercise test or patients with claustrophobia will be excluded. Patients will be asked if there is any chance that they are pregnant. If they are possibly pregnant, they will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global and regional myocardial strain (radial, longitudinal and circumferential) as measured by cardiac MRI.
Time frame: 1 day
Results and safety
The study was stopped early (reason given: PI time constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
Related trials for Fontan Procedure
Not yet recruitingObservational study
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
Fontan Procedure, Fontan Circulation
RecruitingObservational study
Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
Fontan Procedure, Congenital Heart Disease
RecruitingPhase 3
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Fontan Palliation
RecruitingPhase 4
The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure
Fontan, Heart Failure
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
Prevention of Venous Thromboembolism, Congenital Heart Disease
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.
Alexander Lowenthal, MD principal investigator
University of California, San Francisco
Alison Meadows, MD, PhD study chair
University of California, San Francisco
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 Procedure and Hypoplastic Left Heart Syndrome, run by University of California, San Francisco 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 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: stopped early, as of the sponsor's last update on 21 Jan 2020. 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 was stopped early (reason given: PI time constraints). 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?
Global and regional myocardial strain (radial, longitudinal and circumferential) as measured by cardiac MRI. (time frame: 1 day). 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 21 Jan 2020.