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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02847975
Other study ID # Pro00033300
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2013
Est. completion date December 2014

Study information

Verified date August 2018
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 15 Years to 55 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Sodium nitrate
Sodium nitrate will be ingested orally

Locations

Country Name City State
United States Cedars-Sinai Heart Institute Los Angeles California
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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