Status:
TERMINATED
Angiotensin-(1-7) in Peripheral Arterial Disease
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
21-80 years
Phase:
EARLY_PHASE1
Brief Summary
Peripheral arterial disease (PAD) affects over 8 million individuals in the United States alone. This is a form of atherosclerosis in which plaques preferentially build up inside the arteries of the l...
Detailed Description
This is a randomized, double blind, placebo-controlled, crossover study to determine if acute intravenous Ang-(1-7) infusion can reduce systemic inflammation and improve measures of leg blood flow in ...
Eligibility Criteria
Inclusion
- Sex: Male or Female
- Age: 21-80 years of age
- Diagnosed with PAD (e.g. ankle-brachial index below 0.9)
- Fontaine stage II or less (no rest pain)
- Capable of giving informed consent
- Fluent in written and spoken English
Exclusion
- Age less than or equal to 20 years or greater than or equal to 81 years
- Pregnant or nursing woman
- Decisional impairment
- Prisoners
- Alcohol or drug abuse
- Evidence of type I or type II diabetes (fasting glucose \>126 mg/dl or use of anti-diabetic medications)
- History of serious cardiovascular disease (e.g. myocardial infarction within 6 months, symptomatic coronary artery disease, presence of angina pectoris, significant arrhythmia, congestive heart failure, deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, hypertrophic cardiomyopathy) or cerebrovascular disease (e.g. cerebral hemorrhage, stroke, transient ischemic attack).
- History or presence of immunological or hematological disease
- Impaired hepatic function \[aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \> 2 times the upper limit of normal range)
- Impaired renal function (serum creatinine \>2.0 mg/dl)
- Anemia
- Treatment with serotonin-norepinephrine reuptake inhibitors (SNRI) or norepinephrine transporter (NET) inhibitors
- Treatment with phosphodiesterase-5 inhibitors
- Treatment with anticoagulants
- Treatment with chronic systemic glucocorticoid therapy (\>7 consecutive days in 1 month)
- Treatment with any investigational drug in the 1-month preceding the study
- Inability to give, or withdraw, informed consent
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03240068
Start Date
September 1 2017
End Date
March 9 2020
Last Update
May 3 2024
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033