Sodium Nitrate to Improve Blood Flow
1 other identifier
interventional
11
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedAugust 6, 2018
August 1, 2018
1.2 years
April 30, 2014
August 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Sodium nitrate
EXPERIMENTALSodium nitrate will be administered orally and functional sympatholysis assessed before and after treatment
Interventions
Eligibility Criteria
You may qualify if:
- Becker muscular dystrophy
- age 15-55 years of age
- ambulatory
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cedars-Sinai Heart Institute
Los Angeles, California, 90048, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Related 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.
PMID: 23197572BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald G Victor, MD
Cedars-Sinai Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
April 30, 2014
First Posted
July 28, 2016
Study Start
October 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 6, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share
Published http://www.ncbi.nlm.nih.gov/pubmed/26437761