The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02653833
• Date of registration: 14/12/2015
• Prospective Registration: Yes
• Primary sponsor: Cedars-Sinai Medical Center
• Public title: The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy
• Scientific title: Skeletal Muscle Blood Flow in Becker Muscular Dystrophy
• Date of first enrolment: November 1, 2017
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02653833
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Ronald G Victor, MD
• Affiliation: Cedars-Sinai Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy man, aged 18 to 45 years, currently taking no medication. OR

- Clinical diagnosis of Becker Muscular Dystrophy (BMD), aged 18 to 45 years, and
currently taking no medication.

Exclusion Criteria:

- Hypertension, diabetes, heart failure, liver disease

- ECG evidence of prolonged QT interval



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Muscular Dystrophy

Intervention(s)

Drug: Tadalafil 20 MG

Other: beetroot juice extract

Primary Outcome(s)

Change in Skeletal Muscle Blood Flow [Time Frame: At baseline and within one hours after taking beetroot juice or Tadalafil]

Secondary Outcome(s)

Change in Measured Functional Sympatholysis [Time Frame: At baseline, and within an hour after taking beetroot juice or Tadalafil]

Change in Measured Flow Mediated Dilation (FMD) [Time Frame: At baseline, and within an hour after taking beetroot juice or Tadalafil]

Secondary ID(s)

Pro00041688

Source(s) of Monetary Support

Please refer to primary and secondary sponsors