Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of California, San Francisco.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01107990
First received: April 20, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition
Fontan Procedure.
Hypoplastic Left Heart Syndrome
Tricuspid Atresia
Double Inlet Left Ventricle.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single right ventricles
Single left ventricles

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107990

Locations
United States, California
University of California, San-Francisco Recruiting
San-Francisco, California, United States, 94143
Contact: Alison Meadows, MD, PhD    415-353-2756    Alison.meadows@ucsf.edu   
Contact: Alexander Lowenthal, MD    415 476 1802    Alexander.lowenthal@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Alexander Lowenthal, MD University of California, San Francisco
Study Chair: Alison Meadows, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Alison Meadows, MD, PhD, University of California San Francisco
ClinicalTrials.gov Identifier: NCT01107990     History of Changes
Other Study ID Numbers: H64391-34645-01
Study First Received: April 20, 2010
Last Updated: April 20, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Tricuspid Atresia
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Heart Valve Diseases

ClinicalTrials.gov processed this record on April 16, 2014