Angiotensin 1-7 in Obesity Hypertension

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out if the investigational drug angiotensin-(1-7) improves cardiovascular health in patients with obesity and high blood pressure.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amy Arnold
• Collaborator: American Heart Association
• Treatments: Angiotensin I (1-7)

Criteria

Inclusion Criteria:

• Men and women of all races

• Capable of giving informed consent

• Age 18-60 years

• Body mass index (BMI) between 30-40 kg/m2

• Hypertension defined as two or more seated blood pressure readings >130/80 mmHg or use of anti-hypertensive medications

• Satisfactory history and physical exam

Exclusion Criteria:

• Age ≤ 17 or ≥ 61 years

• Pregnant or nursing women

• Decisional impairment

• Prisoners

• Alcohol or drug abuse

• Current smokers

• Highly trained athletes

• Subjects with >5% weight change in the past 3 months

• 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 disorders

• Impaired hepatic function (AST or ALT levels >2 times upper limit of normal range)

• Impaired renal function (serum creatinine >2.0 mg/dl)

• Anemia

• Treatment with serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors

• Treatment with phosphodiesterase-5 inhibitors

• Treatment with anticoagulants (e.g. warfarin)

• 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