Angiotensin 1-7 in Obesity Hypertension
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|ClinicalTrials.gov Identifier: NCT03604289|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : December 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Obesity Hypertension||Drug: Angiotensin-(1-7) Drug: Saline||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Cardiovascular Effects of Angiotensin 1-7 in Obesity Hypertension|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Participants receive intravenous angiotensin-(1-7) at one study visit for 100 minutes total. Angiotensin-(1-7) will be given in escalating doses of 2ng/kg/min, 4ng/kg/min, and 8ng/kg/min. Each of these doses will be infused for 10 minutes. Following the dose escalation, angiotensin-(1-7) will be given at 8ng/kg/min for an additional 70 minutes. Infusion rates will be calculated for each patient based on body mass.
This is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure.
Other Name: Angiotensin I/II (1-7) Acetate
Placebo Comparator: Saline
Participants receive intravenous saline at one study visit for 100 minutes total. 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. Saline will be given in escalating doses for 10 minutes each and then held for 70 minutes at the highest dose.
Saline will be used as the placebo comparator
- Change in brachial artery diameter with reactive hyperemia [ Time Frame: 15 minutes including baseline, cuff inflation, and reactive hyperemia ]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.
- Heart Rate Variability [ Time Frame: 30 minutes ]Resting heart rate variability will be calculated from baseline blood pressure recordings
- Circulating catecholamines [ Time Frame: 5 minutes ]circulating catecholamines will be measured from blood samples
- Change in coronary blood velocity to the cold pressor test [ Time Frame: 20 minutes ]Coronary blood velocity will be measured using duplex ultrasound before, during, and after cold pressor test (hand in ice water for 2 minutes)
- Change in systolic and diastolic blood pressure to the cold pressor test [ Time Frame: 20 minutes ]Blood pressure will be measured continuously with a finger cuff before, during, and after the cold pressor test.
- Change in muscle sympathetic nerve activity to the cold pressor test [ Time Frame: 20 minutes ]Muscle sympathetic nerve activity will be measured using peroneal nerve microneurography before, during, and after the cold pressor test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604289
|Contact: Aimee C. Caufman, BSNemail@example.com|
|United States, Pennsylvania|
|Penn State College of Medicine||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Amy C Arnold, PhD|
|Principal Investigator:||Amy C Arnold, Ph.D.||Penn State College of Medicine|