Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension
NCT Number: NCT06482853
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Obesity|Hypertension
Interventions: DRUG: Angiotensin-(1-7)|DRUG: Saline
Sponsor: Milton S. Hershey Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Sex: ALL
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08
Completion Date: 2029-03
Locations: Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Change in Muscle Sympathetic Nerve Burst Incidence, Muscle sympathetic nerve burst incidence will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Muscle Sympathetic Nerve Amplitude, Muscle sympathetic nerve amplitude will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Muscle Sympathetic Nerve Total Activity, Muscle sympathetic nerve total activity will be measured continuously using peroneal nerve microneurography during angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Systolic Blood Pressure, Blood pressure will be measured continuously with a finger and arm cuff during angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Diastolic Blood Pressure, Blood pressure will be measured continuously with a finger and arm cuff during angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Heart Rate, Heart rate will be measured continuously by electrocardiogram during angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Plasma Catecholamines, Circulating catecholamine levels will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion., 120 minutes
Other Outcome Measures: Change in Angiotensin II, Plasma angiotensin II levels will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Angiotensin-(1-7), Plasma angiotensin-(1-7) levels will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Renin Activity, Plasma renin activity will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Aldosterone, Plasma or serum aldosterone levels will be measured in blood samples obtained at baseline and at the end of angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Heart Rate Variability, Heart rate variability will be calculated from the continuous electrocardiogram recordings obtained during angiotensin-(1-7) versus saline infusion., 120 minutes|Change in Baroreflex Sensitivity, Baroreflex sensitivity will be calculated from the continuous blood pressure and electrocardiogram recordings obtained during angiotensin-(1-7) versus saline infusion., 120 minutes