Sodium Nitrate to Improve Blood Flow

Cedars-Sinai Medical Center

Status and phase: Completed; Phase 1

Conditions: Becker Muscular Dystrophy

Treatments: Dietary Supplement: Sodium nitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02847975

Pro00033300

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Male

Ages: 15 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Sodium nitrate

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sodium nitrate