RECRUITING

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

Conditions

Obesity Hypertension Angiotensin-(1-7)Cardiovascular Sympathetic Nervous System Blood Pressure Endothelial Function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06482853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Men and women of all races * Age 18 to 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 antihypertensive medications * Capable of giving informed consent * Fluent in written and spoken English * Satisfactory history and physical exam	* Age ≤ 17 or ≥ 61 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 * Morbid obesity (BMI \> 40 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

Inclusion Criteria

Exclusion Criteria

* Men and women of all races
* Age 18 to 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 antihypertensive medications
* Capable of giving informed consent
* Fluent in written and spoken English
* Satisfactory history and physical exam

* Age ≤ 17 or ≥ 61 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
* Morbid obesity (BMI \> 40 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

Contacts and Locations

Study Contact

Aimee Cauffman, RN

CONTACT

717-531-1617

acauffman@pennstatehealth.psu.edu

Amy Arnold, PhD

CONTACT

717-531-3674

aarnold5@pennstatehealth.psu.edu

Principal Investigator

Amy Arnold, PhD

PRINCIPAL_INVESTIGATOR

Pennsylvania State University College of Medicine

Study Locations (Sites)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

Amy Arnold, PhD, PRINCIPAL_INVESTIGATOR, Pennsylvania State University College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2029-03

Study Record Updates

Study Start Date2024-12

Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

Angiotensin-(1-7)
Cardiovascular
Sympathetic Nervous System
Blood Pressure
Endothelial Function

Additional Relevant MeSH Terms

Obesity
Hypertension