Clinical trial NCT01107990: Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
Official title: Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fontan Procedure
Hypoplastic Left Heart Syndrome
Tricuspid Atresia
Double Inlet Left Ventricle
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 13
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects: Patients with univentricular hearts who have undergone a Fontan procedure will be recruited for participation in the study.

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Global and regional myocardial strain (radial, longitudinal and circumferential) as measured by cardiac MRI.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San-Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alexander Lowenthal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Alison Meadows, MD, PhD
role: STUDY_CHAIR
References: