Peripheral Artery Disease Clinical Trial
— ATLASOfficial title:
The Effects of ATLAS (Arginine Tetrahydrobiopterin L-Ascorbate) Therapy on Nitric Oxide Bioavailability and Pain-free Walking in Patients With Intermittent Claudication
This study will focus on people with claudication from peripheral arterial disease. The investigators are researching whether a multicomponent therapeutic can increase the production of Nitric Oxide in the blood and whether that leads to an improvement in pain free walking distance and overall physical activity.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - PAD as demonstrated by an ABI <0 .9 in one leg or TBI less than <0.7 in patients with an ABI >1.3 (non compressible vessels) - Rutherford Classification II, III - Age >18 years old - Willingness to discontinue phosphodiesterase (PDE) 5 inhibitors such as Viagra, Cialis, Levitra, Revatio - Willingness to discontinue phosphodiesterase (PDE) 3inhibitors cilostazol, milrinone or Vesnarinone - Willing and able to comply with all study procedures - Willing and able to provide informed consent - Sexually active subjects willing to use an acceptable method of contraception while participating in the study Exclusion Criteria: - Hypotension defined as a systolic blood pressure less than 100mmhg systolic at screening or baseline visit - Critical Leg Ischemia (Rutherford Classification IV, V, VI) - Surgical intervention to alleviate symptoms of claudication in the study leg within the past 6 months or any endovascular interventions within 3 months or who is scheduled to undergo surgical revascularization in the next 6 month - Walking limited by reasons other than claudication (e.g. arthritis, lung disease, severe neuropathy, lower extremity amputation except single digits) - Serum creatinine >1.5mg/dl or Hepatic enzymes >2X the upper limit of normal - Serum potassium greater than 5.0 or use of a potassium sparing diuretic at screening - Pregnant, breast feeding or planning to become pregnant (subject or partner) at any time during the study. - Myocardial Infarction, Cerebrovascular Accident or deep vein thrombosis within 12 months of screening - Known history of nephrolithiasis - History of ever having a seizure - Concurrent disease or condition that would interfere with study participation or safety such as bleeding disorders, organ transplant, long term immunosuppression (excluding inhaled steroids), current neoplasm or severe gastroesophageal reflux - History of vertigo or syncope within the past 10 years - Enrollment in another drug or device study within 30 days of screening - Required treatment with a drug known to inhibit folate metabolism (e.g. Methotrexate) - Taking any of the following medications; PDE3 Inhibitors, PDE5 inhibitors, trental, nitrates, ginkgo biloba, levodopa, warfarin, - Axillary lymph node dissection - Presence of an amputation except single digits in either leg - Preexisting illness that limits ambulation such as severe COPD, class III-IV heart failure, severe arthritis or back pain - Glucose-6-dehydrogenase deficiency |
Country | Name | City | State |
---|---|---|---|
United States | UMASS Memorial Healthcare - University Campus | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Louis Messina | BioMarin Pharmaceutical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nitric Oxide bioavailability | Nitric Oxide bioavailability as measured by flow mediated dilatation (FMD). | 90 days |
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