Effects of Sodium Nitrate on Blood Flow in Becker Muscular Dystrophy

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Becker Muscular Dystrophy

In brief

This study is intended to build on a growing body of literature showing a blood flow abnormality in patients with Becker muscular dystrophy. The investigators' laboratory recently showed that this blood flow abnormality could be corrected by a single oral dose of the drug Tadalafil (also known as Cialis). The investigators now wish to replicate these exciting results using a common nitric oxide donor (sodium nitrate).

Key facts

Study ID

NCT02147639

Run by

Cedars-Sinai Medical Center

People needed

19

Starts

2013-10-01

Expected to finish

2014-05-01

Last updated by the study team

2020-01-14

Who can join

Age: 15 and older, up to 45. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men 15-55 years of age with a pre-existing diagnosis of Becker Muscular Dystrophy by a clinical neurologist (based on clinical criteria plus previous muscle biopsy analysis and/or DNA analysis).

You may not qualify if…

• Any evidence of cardiopulmonary disease by history or by physical examination
• History of hypertension or blood pressure averaging ≥140/90 mmHg
• Diabetes mellitus or other systemic illness
• Heart failure by clinical exam, elevated BNP, or heart failure medication
• Serum creatinine ≥ 1.5 mg/dL
• Any history of substance abuse (including alcohol)
• Any history of psychiatric illness

Where it is running

• Cedars-Sinai Heart Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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