Becker Muscular Dystrophy Clinical Trial
Verified date | October 2017 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
the Investigator will test the hypothesis that short term PDE5A inhibition (with tadalafil) will reduce post-exercise edema by MRI in males with Becker Muscular Dystrophy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 15 Years to 55 Years |
Eligibility |
Patient with BMD - Inclusion Criteria: - diagnosis of BMD confirmed by muscle biopsy or DNA analysis - age 15-55 years of age - ambulatory - no clinical evidence of heart failure Exclusion Criteria: - hypertension, diabetes, or heart failure by standard clinical criteria - elevated BNP (brain natriuretic peptide) level (>100 pg/ml) - left ventricular ejection fraction < 50% - wheelchair bound - cardiac rhythm disorder, specifically: rhythm other than sinus, sinoventricular tachycardia, atrial fibrillation, ventricular tachycardia - continuous ventilatory support - liver disease - renal impairment - contraindications to tadalafil (use of nitrates, alpha-blockers, Cytochrome P450 (CYP3A )inhibitors, amlodipine, or other phosphodiesterase 5A inhibitors) Healthy Control Participants - Inclusion Criteria: - age 15-55 years of age - ambulatory - no clinical evidence of heart failure Exclusion Criteria: - hypertension, diabetes, or heart failure by standard clinical criteria - elevated BNP (brain natriuretic peptide) level (>100 pg/ml) - left ventricular ejection fraction < 50% - cardiac rhythm disorder, specifically: rhythm other than sinus, sinoventricular tachycardia, atrial fibrillation, ventricular tachycardia - liver disease - renal impairment - unsatisfactory completion of the sympatholysis protocol - BMI < 35 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in post-exercise muscle edema by MRI. | Pre vs. 48 hours post treatment change |
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