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completed

Sodium Nitrate to Improve Blood Flow

key information

study id #: NCT02847975

condition: Becker Muscular Dystrophy

status: completed

purpose:

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.

intervention: Sodium nitrate

mechanism of action: Nitrate supplement to alter funcitonal muslce ischaemia

results: https://clinicaltrials.gov/ct2/show/results/NCT02847975

last updated: November 21, 2018

study details

start date: October 2013

estimated completion: December 2014

phase of development: Phase 1

size / enrollment: 11

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.

inclusion criteria:

• Eligible Sexes:

• 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

study contacts

sponsor: Cedars Sinai Medical Center

investigators: Ronald G Victor, MD

trial center locations: United States

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