Sodium Nitrate to Improve Blood Flow

Phase 1

Completed

• Conditions: Becker Muscular Dystrophy
• Interventions: Dietary Supplement: Sodium nitrate

• 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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-04-30
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-06

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

Arm && Interventions

Group	Intervention	Description
Sodium nitrate	Sodium nitrate	Sodium nitrate will be administered orally and functional sympatholysis assessed before and after treatment

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.

Trial Locations

Locations (2)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Heart Institute; 🇺🇸 Los Angeles, California, United States