The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

  • STATUS
    Recruiting
  • End date
    Feb 25, 2023
  • participants needed
    10
  • sponsor
    University of Massachusetts, Worcester
Updated on 25 October 2021
pain-free
arterial disease
intermittent claudication
cilostazol

Summary

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.

Description

The primary objective of this study is to show that ATLAS Therapy, (L-Arginine; Tetrahydrobiopterin; L-Ascorbate) is bioavailable in humans and exerts a measurable effect on its in vivo biological signature, Flow Mediated Vasodilation (FMD) in people with intermittent claudication caused by peripheral arterial disease. This will be a Phase I / dose finding study. All subjects will receive 2 different drug doses of the Kuvan the first 45 days they will receive 10 mg/kg/day. The second 45 days they will receive 20/mg/kg/day.

Details
Condition peripheral artery disease, Circulation Disorders, Intermittent Claudication, Vascular Diseases, peripheral arterial diseases, Peripheral Arterial Disease (PAD), Atherosclerosis, peripheral arterial disease, Peripheral Vascular Disease, Claudication, Peripheral vascular disease
Treatment L-arginine, Tetrahydrobiopterin 10 mg/kg, Tetrahydrobiopterin 20 mg/kg, L-Ascorbate, L-Ascorbate
Clinical Study IdentifierNCT04800692
SponsorUniversity of Massachusetts, Worcester
Last Modified on25 October 2021

Eligibility

Yes No Not Sure

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
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