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Sodium Nitrate to Improve Blood Flow

Primary Purpose

Becker Muscular Dystrophy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sodium nitrate
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Becker Muscular Dystrophy focused on measuring Becker, dystrophy, sympatholysis

Eligibility Criteria

15 Years - 55 Years (Child, Adult)MaleAccepts 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

Sites / Locations

  • Cedars-Sinai Heart Institute
  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sodium nitrate

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 30, 2014
Last Updated
August 2, 2018
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02847975
Brief Title
Sodium Nitrate to Improve Blood Flow
Official Title
Sodium Nitrate to Improve Blood Flow
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Becker Muscular Dystrophy
Keywords
Becker, dystrophy, sympatholysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium nitrate
Arm Type
Experimental
Arm Description
Sodium nitrate will be administered orally and functional sympatholysis assessed before and after treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium nitrate
Intervention Description
Sodium nitrate will be ingested orally
Primary Outcome Measure Information:
Title
change in muscle tissue oxygenation
Description
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald G Victor, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Heart Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Published http://www.ncbi.nlm.nih.gov/pubmed/26437761
Citations:
PubMed Identifier
23197572
Citation
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.
Results Reference
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Sodium Nitrate to Improve Blood Flow

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