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Sodium Nitrate to Improve Blood Flow

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ClinicalTrials.gov Identifier: NCT02847975
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ron Victor, Cedars-Sinai Medical Center

Brief Summary:
Investigators recently showed that tadalafil restores functional sympatholysis in patients with Becker muscular dystrophy (BMD). If tadalafil restores functional sympatholysis in BMD via the NO-cyclic guanosine monophosphate pathway, then functional sympatholysis should also be restored by sodium nitrite— which is an indirect nitric oxide donor.

Condition or disease Intervention/treatment Phase
Becker Muscular Dystrophy Dietary Supplement: Sodium nitrate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sodium Nitrate to Improve Blood Flow
Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Sodium nitrate
Sodium nitrate will be administered orally and functional sympatholysis assessed before and after treatment
Dietary Supplement: Sodium nitrate
Sodium nitrate will be ingested orally




Primary Outcome Measures :
  1. change in muscle tissue oxygenation [ Time Frame: change from baseline to post treatment (3-4 hours) ]
    The pre-specified primary outcome is the pre vs. post treatment change in functional sympatholysis measured by muscle oxygenation.



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Ages Eligible for Study:   15 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Becker muscular dystrophy
  • age 15-55 years of age
  • ambulatory

Exclusion Criteria:

  • hypertension, diabetes, or heart failure by standard clinical criteria
  • elevated brain natriuretic peptide level (>100 pg/ml)
  • Left ventricular ejection fraction < 50%
  • cardiac rhythm disorder, specifically: rhythm other than sinus, supraventricular tachycardia, atrial fibrillation, ventricular tachycardia, heart block
  • continuous ventilatory support
  • liver disease
  • renal impairment
  • history of asthma or bronchospasm
  • use of any medications other than common supplements
  • unable to perform handgrip exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847975


Locations
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United States, California
Cedars-Sinai Heart Institute
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Ronald G Victor, MD Cedars-Sinai Medical Center

Publications:
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Responsible Party: Ron Victor, Professor of Medicine, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02847975     History of Changes
Other Study ID Numbers: Pro00033300
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Published http://www.ncbi.nlm.nih.gov/pubmed/26437761

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ron Victor, Cedars-Sinai Medical Center:
Becker
dystrophy
sympatholysis
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked