Status:
TERMINATED
Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension
Lead Sponsor:
Vanderbilt University
Conditions:
Hypertension
Hypertension, Essential
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to better understand the cardiovascular effects of the vasodilatory peptide Angiotensin (1-7) in human hypertension. In this study, the investigators will test the hypothe...
Detailed Description
Pharmacologic approaches to increase levels or actions of the vasodilatory peptide Angiotensin (1-7) are currently in development for the treatment of hypertension based on findings from animal studie...
Eligibility Criteria
Inclusion
- Males and females of all races between 18 and 60 years of age
- Hypertension defined by two or more properly measured seated blood pressure readings \>130/85 mmHg. This will allow us to include subjects with "pre-hypertension."
- Able and willing to provide informed consent
Exclusion
- Pregnancy or breast feeding
- Current smokers or history of heavy smoking (\>2 packs/day)
- History of alcohol or drug abuse
- Previous allergic reaction to study medications
- Evidence of type I or type II diabetes (i.e. fasting glucose \>126 mg/dl, use of anti-diabetic medications)
- Cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy
- History of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack
- History or presence of immunological or hematological disorders
- Impaired hepatic function \[aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) \> 2.0 x upper limit of normal range\]
- Impaired renal function (serum creatinine \>1.5 mg/dl)
- Anemia (hemoglobin \<13.5 g/dl in males or \<12.5 g/dl in females)
- Treatment with phosphodiesterase 5 inhibitors
- Treatment with anticoagulants
- Treatment with chronic systemic glucocorticoid therapy (more than 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
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e. clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02245230
Start Date
January 1 2015
End Date
December 1 2023
Last Update
January 9 2024
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232