Sodium Nitrate to Improve Blood Flow
Phase 1
Completed
- Conditions
- Becker Muscular Dystrophy
- Registration Number
- NCT02847975
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 11
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method change in muscle tissue oxygenation 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Cedars-Sinai Heart Institute
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Cedars-Sinai Heart Institute🇺🇸Los Angeles, California, United States