Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension
Recruiting · NCT06482853 · Interventional (participants receive a specific treatment) · Lead sponsor: Milton S. Hershey Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Angiotensin-(1-7)Saline
What this trial is about
Obesity is a global health concern that is associated with high blood pressure and an increased risk for developing cardiovascular disease. The purpose of this study is to find out if the investigational drug angiotensin-(1-7) can improve cardiovascular health in people with obesity and high blood pressure.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Men and women of all races
- Age 18 to 65 years
- Body mass index (BMI) between 30-45 kg/m2
- Pre-hypertension (defined as two or more seated blood pressure readings \>120/80 mmHg) or hypertension (defined as two or more seated blood pressure readings \>130/80 mmHg or use of antihypertensive medications)
- Capable of giving informed consent
- Fluent in written and spoken English
- Satisfactory history and physical exam
Exclusion criteria
- Age ≤ 17 or ≥ 66 years
- Taking more than two antihypertensive medications
- Secondary causes of hypertension (e.g., pheochromocytoma, primary aldosteronism, aortic coarctation, adrenal disease)
- Pregnant or nursing women
- Women taking hormone replacement therapy within 6 months
- Decisional impairment
- Prisoners
- Alcohol or drug abuse
- Current smokers
- Highly trained athletes
- Subjects with \>5% weight change in the past 3 months
- BMI \> 45 kg/m2
- 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 \[aspartate aminotransferase (AST) or alanine transaminase (ALT) levels \>2 times upper limit of normal range\]
- Impaired renal function (serum creatinine \>2.0 mg/dl)
- Anemia
- Treatment with drugs increasing sympathetic activity \[e.g., serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine transporter (NET) inhibitors, stimulants\]
- 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
Where it is running
2 locations listed across 1 US state.
- Penn State Milton S. Hershey Medical Center - Hershey, Pennsylvania, United States
- Penn State Milton S. Hershey Medical Center - Hershey, Pennsylvania, United States