Study Results
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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COMPLETED
PHASE1
5 participants
INTERVENTIONAL
2015-06-30
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sodium Nitrate (Beetroot Juice)
Sodium nitrate in the form of beetroot juice will be administered orally. Patients will be assessed with a number of functional muscle assessments.
Sodium Nitrate
Patients will be given sodium nitrate daily in the form of beetroot juice.
Interventions
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Sodium Nitrate
Patients will be given sodium nitrate daily in the form of beetroot juice.
Eligibility Criteria
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Inclusion Criteria
* Age 15-45 years of age
* Ambulatory
* No clinical evidence of heart failure
* Maximum voluntary contraction, measured by hand grip dynamometer, of 20-40 kg
Exclusion Criteria
* Elevated B-type Natruiretic Peptide level (\>100 pg/ml)
* Left Ventricular Ejection Fraction \< 50%
* Wheelchair bound
* Cardiac rhythm disorder, specifically: rhythm other than sinus, Supraventricular Tachycardia, atrial fibrillation, ventricular tachycardia
* Continuous ventilatory support
* Liver disease
* Renal impairment
* Maximum voluntary contraction of less than 20 kg or greater than 40 kg
* Ventilation Devices (Continuous Positive Airway Pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP))
15 Years
45 Years
MALE
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ronald G Victor, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Other Identifiers
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Pro35228
Identifier Type: -
Identifier Source: org_study_id
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