Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension
2 other identifiers
interventional
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 obesity
Started Jan 2025
Longer than P75 for early_phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2024
CompletedFirst Posted
Study publicly available on registry
July 1, 2024
CompletedStudy Start
First participant enrolled
January 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
September 19, 2025
September 1, 2025
4.1 years
June 26, 2024
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Muscle Sympathetic Nerve Burst Rate
Muscle sympathetic nerve burst rate will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion.
120 minutes
Change in Brachial Artery Diameter
A blood pressure cuff will be inflated to a suprasystolic pressure for 5 minutes then deflated. Brachial artery diameter will be measured continuously before, during, and after cuff inflation using duplex ultrasound at baseline and at the end of angiotensin-(1-7) versus saline infusion.
120 minutes
Secondary Outcomes (7)
Change in Muscle Sympathetic Nerve Burst Incidence
120 minutes
Change in Muscle Sympathetic Nerve Amplitude
120 minutes
Change in Muscle Sympathetic Nerve Total Activity
120 minutes
Change in Systolic Blood Pressure
120 minutes
Change in Diastolic Blood Pressure
120 minutes
- +2 more secondary outcomes
Other Outcomes (6)
Change in Angiotensin II
120 minutes
Change in Angiotensin-(1-7)
120 minutes
Change in Renin Activity
120 minutes
- +3 more other outcomes
Study Arms (2)
Angiotensin-(1-7)
EXPERIMENTALParticipants will receive intravenous angiotensin-(1-7) at one study visit for a total of 120 minutes. Angiotensin-(1-7) will be given in escalating doses of 2 ng/kg/min, 4 ng/kg/min, and 8 ng/kg/min. Each of these doses will be infused for 10 minutes. Following this 30 minute dose escalation period, angiotensin-(1-7) will be given at 8 ng/kg/min for an additional 90 minutes. Infusion rates will be calculated for each patient based on body mass.
Saline
PLACEBO COMPARATORParticipants receive intravenous saline at one study visit for a total of 120 minutes. The volume of saline will match the volume of angiotensin-(1-7) infused. Infusion rates will be calculated for each patient based on body mass.
Interventions
This is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure.
Saline will be used as the placebo comparator.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Arnold, PhD
Pennsylvania State University College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 26, 2024
First Posted
July 1, 2024
Study Start
January 23, 2025
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be available to other researchers.