Hypoplastic Left Heart Syndrome Clinical Trial
Official title:
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
Verified date | January 2020 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 13 |
Est. completion date | September 20, 2012 |
Est. primary completion date | September 20, 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San-Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global and regional myocardial strain (radial, longitudinal and circumferential) as measured by cardiac MRI. | 1 day |
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