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Trial record 9 of 88 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Dystrophies"

Sodium Nitrate for Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT02434627
Recruitment Status : Recruiting
First Posted : May 5, 2015
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):

April 28, 2015
May 5, 2015
October 17, 2016
June 2015
October 2016   (Final data collection date for primary outcome measure)
Change in maximal handgrip strength [ Time Frame: Change from baseline in handgrip strength at 3 months ]
Same as current
Complete list of historical versions of study NCT02434627 on ClinicalTrials.gov Archive Site
  • Change in muscle function - Performance of Upper Limb Scale [ Time Frame: Change from baseline in muscle function - the Performance of Upper Limb Scale at 3 months ]
    Change in functional muscle assessment as measured by the Performance of Upper Limb Scale
  • Change in muscle tissue markers - histology and proteomics [ Time Frame: Change from baseline in muscle tissue markers at 3 monthss ]
    Change in tissue markers such as neuronal Nitric Oxide Synthase (nNOS) content and location and nitrosative stress by histology and proteomics
  • Change in systolic wall strain - imaging [ Time Frame: Change from baseline in cardiac systolic wall strain at 3 months ]
    Change in the cardiac wall strain as measured by Cardiac Magnetic Resonance Imaging
  • Change in muscle function - North Star Ambulatory Assessment [ Time Frame: Change from baseline in muscle function - North Star Ambulatory Assessment at 3 months ]
    Change in functional muscle assessment as measured by the North Star Ambulatory Assessment
  • Change in muscle function - 6 minute walk test [ Time Frame: Change from baseline in muscle function - 6 minute walk test at 3 months ]
    Change in functional muscle assessment as measured by the 6 minute walk test
Same as current
Not Provided
Not Provided
 
Sodium Nitrate for Muscular Dystrophy
Sodium Nitrate for Muscular Dystrophy
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Becker Muscular Dystrophy
Drug: Sodium Nitrate
Patients will be given sodium nitrate daily in the form of beetroot juice.
Experimental: Sodium Nitrate (Beetroot Juice)
Sodium nitrate in the form of beetroot juice will be administered orally. Patients will be assessed with a number of functional muscle assessments.
Intervention: Drug: Sodium Nitrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
June 2017
October 2016   (Final data collection date for primary outcome measure)

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))
Sexes Eligible for Study: Male
15 Years to 45 Years   (Child, Adult)
No
Contact: Mohammad Rashid Mohamad.Rashid@cshs.org
United States
 
 
NCT02434627
Pro35228
No
Not Provided
Plan to Share IPD: No
Ron Victor, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: Ronald G Victor, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP