Sodium Nitrate to Improve Blood Flow

Becker Muscular Dystrophy Clinical Trial

Official title:

Sodium Nitrate to Improve Blood Flow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847975
• Other study ID #: Pro00033300
• Status: Completed
• Phase: Phase 1
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Becker Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Dietary Supplement:
• Sodium nitrate
Sodium nitrate will be ingested orally

Locations

Country	Name	City	State
United States	Cedars-Sinai Heart Institute	Los Angeles	California
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Martin EA, Barresi R, Byrne BJ, Tsimerinov EI, Scott BL, Walker AE, Gurudevan SV, Anene F, Elashoff RM, Thomas GD, Victor RG. Tadalafil alleviates muscle ischemia in patients with Becker muscular dystrophy. Sci Transl Med. 2012 Nov 28;4(162):162ra155. doi: 10.1126/scitranslmed.3004327. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in muscle tissue oxygenation	The pre-specified primary outcome is the pre vs. post treatment change in functional sympatholysis measured by muscle oxygenation.	change from baseline to post treatment (3-4 hours)