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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02847975
Date of registration: 30/04/2014
Prospective Registration: No
Primary sponsor: Cedars-Sinai Medical Center
Public title: Sodium Nitrate to Improve Blood Flow
Scientific title: Sodium Nitrate to Improve Blood Flow
Date of first enrolment: October 2013
Target sample size: 11
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02847975
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Ronald G Victor, MD
Address: 
Telephone:
Email:
Affiliation:  Cedars-Sinai Medical Center
Key inclusion & exclusion criteria

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



Age minimum: 15 Years
Age maximum: 55 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Becker Muscular Dystrophy
Intervention(s)
Dietary Supplement: Sodium nitrate
Primary Outcome(s)
change in muscle tissue oxygenation [Time Frame: change from baseline to post treatment (3-4 hours)]
Secondary Outcome(s)
Secondary ID(s)
Pro00033300
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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