Sodium Nitrate for Muscular Dystrophy



Status:Recruiting
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:15 - 45
Updated:4/21/2016
Start Date:June 2015
End Date:June 2016
Contact:Mohammad Rashid
Email:Mohamad.Rashid@cshs.org

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Trial Summary
Trial Overview
Inclusion Criteria
The investigators' previous work in males with Becker Muscular Dystrophy shows that
functional sympatholysis is restored by acute inorganic nitrate supplementation. This was
translated from work using the mdx mouse model of dystrophinopathy. Recent work has shown
that there is a frank improvement in grip strength when mdx mice are treated with an
inorganic Nitric Oxide (NO) donor. The purpose of this study is to determine if chronic
treatment with an inorganic NO donor can benefit patients with muscular dystrophy beyond
blood flow regulation.


Inclusion Criteria:

- Clinical diagnosis of muscular dystrophy

- Age 15-45 years of age

- Ambulatory

- No clinical evidence of heart failure

- Maximum voluntary contraction, measured by hand grip dynamometer, of 20-40 kg

Exclusion Criteria:

- Hypertension, diabetes, or heart failure by standard clinical criteria

- Elevated B-type Natruiretic Peptide level (>100 pg/ml)

- Left Ventricular Ejection Fraction < 50%

- Wheelchair bound

- Cardiac rhythm disorder, specifically: rhythm other than sinus, Supraventricular
Tachycardia, atrial fibrillation, ventricular tachycardia

- Continuous ventilatory support

- Liver disease

- Renal impairment

- Contraindications to NO donors (use of nitrates, alpha-blockers, CYP3A inhibitors,
amlodipine, or Phosphodiesterase type 5 (PDE5) inhibitors) Glucocorticoid therapy and
prophylactic use of Angiotensin Converting Enzyme (ACE) inhibitors and beta-blockers
for cardiac protection will not be exclusion criteria.

- Maximum voluntary contraction of less than 20 kg or greater than 40 kg

- Ventilation Devices (Continuous Positive Airway Pressure (CPAP), Bilevel Positive
Airway Pressure (BiPAP))
We found this trial at
1
site
Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 424-315-2501
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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