Sodium Nitrate to Improve Blood Flow

Cedars-Sinai Medical Center11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Becker Muscular Dystrophy

Interventions

Sodium nitrateDIETARY_SUPPLEMENT

Sodium nitrate will be ingested orally

Eligibility

Sex: MALEMin age: 15 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Cedars-Sinai Heart Institute

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

change in muscle tissue oxygenation

The pre-specified primary outcome is the pre vs. post treatment change in functional sympatholysis measured by muscle oxygenation.

Time frame: change from baseline to post treatment (3-4 hours)

Data from ClinicalTrials.gov

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