Cardiovascular Effects of Angiotensin-(1-7) in Obesity Hypertension
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMilton S. Hershey Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Angiotensin-(1-7)
DrugThis is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure.
Saline
DrugSaline will be used as the placebo comparator.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Angiotensin-(1-7)Experimental treatment 1 intervention
Group B: SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
120 minutes2
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.
Time frame
120 minutesSecondary outcomes
1
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.
Time frame
120 minutes2
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.
Time frame
120 minutes3
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.
Time frame
120 minutes4
Change in Systolic Blood Pressure
Blood pressure will be measured continuously with a finger and arm cuff during angiotensin-(1-7) versus saline infusion.
Time frame
120 minutesOther outcomes
1
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.
Time frame
120 minutes2
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.
Time frame
120 minutes3
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.
Time frame
120 minutes4
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.
Time frame
120 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov