Effects of ATLAS Therapy on Nitric Oxide Levels in Patients with Claudication
The Effects of ATLAS (Arginine Tetrahydrobiopterin L-Ascorbate) Therapy on Nitric Oxide Bioavailability and Pain-free Walking in Patients With Intermittent Claudication
This study is testing if a new therapy can boost nitric oxide levels and help people with leg pain from peripheral artery disease walk more comfortably.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT04800692 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of ATLAS Therapy, which includes L-Arginine, Tetrahydrobiopterin, and L-Ascorbate, on nitric oxide bioavailability in patients suffering from intermittent claudication due to peripheral artery disease. The primary goal is to determine if this multicomponent therapy can enhance nitric oxide production and improve pain-free walking distance and overall physical activity. Participants will receive two different doses of the therapy over a 90-day period, allowing researchers to assess its effects on vascular function as measured by Flow Mediated Vasodilation (FMD).
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with diagnosed peripheral artery disease and intermittent claudication.
Not a fit: Patients with critical leg ischemia or those who have had recent surgical interventions for claudication may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve walking ability and quality of life for patients with intermittent claudication.
How similar studies have performed: Other studies have explored similar therapeutic approaches, but the specific combination used in this trial is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Worcester, Massachusetts
- UMASS Memorial Healthcare - University Campus — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Louis M Messina, MD — UMASS Medical School
- Study coordinator: Shauneen Valliere, MSN
- Email: shauneen.valliere@umassmed.edu
- Phone: 508-856-1767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.