Effects of Angiotensin-(1-7) on Heart Health in Obese Patients with High Blood Pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether the investigational drug angiotensin-(1-7) can enhance cardiovascular health in individuals suffering from obesity and hypertension. It employs a randomized, double-blind, placebo-controlled, crossover design, where participants will receive either angiotensin-(1-7) or saline through intravenous infusion. The study will measure various cardiovascular parameters, including blood pressure, heart rate, and endothelial function, over two outpatient visits. Each visit will last approximately four hours, with continuous monitoring of sympathetic nerve activity and blood samples collected for analysis.

Why it matters

Who can join: the full rules

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's running

• Penn State Milton S. Hershey Medical Center
  Hershey, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Amy Arnold, PhD — Pennsylvania State University College of Medicine
• Study coordinator: Aimee Cauffman, RN
• Email: acauffman@pennstatehealth.psu.edu
• Phone: 717-531-1617

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.