Sodium Nitrate to Improve Blood Flow

NCT ID: NCT02847975

Last Updated: 2018-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Becker Muscular Dystrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sodium nitrate

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

Group Type EXPERIMENTAL

Sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Sodium nitrate will be ingested orally

Interventions

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Sodium nitrate

Sodium nitrate will be ingested orally

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ron Victor

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald G Victor, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Heart Institute

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23197572 (View on PubMed)

Other Identifiers

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Pro00033300

Identifier Type: -

Identifier Source: org_study_id

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