Cardiac Outcome Measures in Children With Muscular Dystrophy

This study has been completed.

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Cooperative International Neuromuscular Research Group

ClinicalTrials.gov Identifier:

NCT01066455

First received: February 9, 2010

Last updated: January 10, 2013

Last verified: January 2013

History of Changes

Purpose

The purpose of the research study is to evaluate different cardiac measures that are obtained by echocardiographic tests in patients with muscular dystrophy.

Condition
Duchenne Muscular Dystrophy Becker Muscular Dystrophy Limb Girdle Muscular Dystrophy


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Cross-Sectional
Official Title:	PITT1109: Cardiac Outcome Measures in Children With Muscular Dystrophy

Resource links provided by NLM:

Genetics Home Reference related topics: Duchenne and Becker muscular dystrophy limb-girdle muscular dystrophy

MedlinePlus related topics: Muscular Dystrophy

Genetic and Rare Diseases Information Center resources: Muscular Dystrophy Duchenne Muscular Dystrophy Becker Muscular Dystrophy Limb-girdle Muscular Dystrophy

U.S. FDA Resources

Further study details as provided by Cooperative International Neuromuscular Research Group:

Biospecimen Retention: None Retained

Prospective collection of blood sample for BNP measurements.


Enrollment:	48
Study Start Date:	January 2010
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

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.

Eligibility


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


Responsible Party:	Cooperative International Neuromuscular Research Group
ClinicalTrials.gov Identifier:	NCT01066455 History of Changes
Other Study ID Numbers:	PITT1109
Study First Received:	February 9, 2010
Last Updated:	January 10, 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

ClinicalTrials.gov processed this record on July 21, 2017

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