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NCT01066455 Clinical Trial

Cardiac Outcome Measures in Children With Muscular Dystrophy

Duchenne Muscular Dystrophy Clinical Trial

Official title:
PITT1109: Cardiac Outcome Measures in Children With Muscular Dystrophy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01066455
Other study ID # PITT1109
Secondary ID
Status Completed
Phase N/A
First received February 9, 2010
Last updated January 10, 2013
Start date January 2010
Est. completion date May 2012

Study information
Verified date January 2013
Source Cooperative International Neuromuscular Research Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 18 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Texas Children's Hospital Houston Texas
United States University of Pittsburgh Pittsburgh Pennsylvania
United States University of California Davis Sacramento California
United States Washington University St. Louis St. Louis Missouri
United States Children's National Medical Center Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
Cooperative International Neuromuscular Research Group National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

See also
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Completed NCT00758225 - Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension) Phase 2
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Recruiting NCT01484678 - Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy
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Terminated NCT01753804 - A Prospective Natural History Study of Progression of Subjects With Duchenne Muscular Dystrophy. N/A
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