Effects of Angiotensin-(1-7) on Heart Health in Obese Patients with High Blood Pressure
Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension
This study is testing if a new drug called angiotensin-(1-7) can improve heart health in obese patients with high blood pressure.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT06482853 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a BMI between 30-40 kg/m2 and hypertension.
Not a fit: Patients with secondary causes of hypertension, morbid obesity, or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health and management strategies for patients with obesity-related hypertension.
How similar studies have performed: While the specific use of angiotensin-(1-7) in this context is novel, similar studies have shown promise in targeting cardiovascular health in hypertensive populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hershey, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.