ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiac Outcome Measures in Children With Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01066455
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : January 11, 2013
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Cooperative International Neuromuscular Research Group

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the research study is to evaluate different cardiac measures that are obtained by echocardiographic tests in patients with muscular dystrophy.

Condition or disease
Duchenne Muscular Dystrophy Becker Muscular Dystrophy Limb Girdle Muscular Dystrophy

Detailed Description:

The research study will include 50 participants aged 8 to 18 years old (before 18th birthday) with Duchenne, Becker, or autosomal recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies.

Participants will be seen in one of five Cooperative International Neuromuscular Research Group (CINRG) centers located in the United States.

All study assessments will be completed in the same day and include reviewing past medical and surgical history, collecting vital signs, collecting cardiac measures through echocardiographic tests.


Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: PITT1109: Cardiac Outcome Measures in Children With Muscular Dystrophy
Study Start Date : January 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   None Retained
Prospective collection of blood sample for BNP measurements.

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
8 to 18 years old Confirmed diagnosis of Duchenne, Becker, or autosomal recessive limb-girdle muscular dystrophy (LGMD: 2C-2F and 2I)
Criteria

Inclusion Criteria:

  • Participants must be between the ages of 8 and 18 years old
  • Confirmed diagnosis of muscular dystrophy (DMD, BMD, or LGMD 2C-2F and 2I)

Exclusion Criteria:

  • Investigator assessment of inability to comply with protocol
  • History of a congenital cardiac defect or other cardiac disease unrelated to muscular dystrophy
Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066455


Locations
United States, California
University of California Davis
Sacramento, California, United States
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States
United States, Missouri
Washington University St. Louis
St. Louis, Missouri, United States
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Texas Children's Hospital
Houston, Texas, United States
Sponsors and Collaborators
Cooperative International Neuromuscular Research Group
National Institutes of Health (NIH)
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Cooperative International Neuromuscular Research Group
ClinicalTrials.gov Identifier: NCT01066455     History of Changes
Other Study ID Numbers: PITT1109
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: January 2013

Keywords provided by Cooperative International Neuromuscular Research Group:
Cardiac
Muscular Dystrophy
Prospective
Pediatric
Echocardiogram

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Dystrophies, Limb-Girdle
Muscular Disorders, Atrophic
Muscular Diseases
 Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked