RecruitingEarly Phase 1NCT06482853

Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension


Sponsor

Milton S. Hershey Medical Center

Enrollment

52 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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 Criteria24

  • 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

Interventions

DRUGAngiotensin-(1-7)

This is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure.

DRUGSaline

Saline will be used as the placebo comparator.


Locations(1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

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NCT06482853


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