Sodium Nitrate to Improve Blood Flow

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.

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Key information

Conditions

Becker Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

15 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium nitrate

Dietary Supplement

Sodium nitrate will be ingested orally

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jul 28, 2016
Registry last updated: Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed