Blood Pressure Lowering Effects of Angiotensin-(1-7) in Primary Autonomic Failure
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ClinicalTrials.gov Identifier: NCT02591173 |
Recruitment Status :
Terminated
(Difficulty recruiting)
First Posted : October 29, 2015
Last Update Posted : January 12, 2021
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Condition or disease | Intervention/treatment | Phase |
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Autonomic Nervous System Disorders Pure Autonomic Failure Shy-Drager Syndrome Orthostatic Hypotension, Dysautonomic | Drug: Angiotensin-(1-7) Drug: Saline | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Blood Pressure Lowering Effects of Angiotensin-(1-7) in Primary Autonomic Failure |
Actual Study Start Date : | February 2016 |
Actual Primary Completion Date : | July 2020 |
Actual Study Completion Date : | July 2020 |

Arm | Intervention/treatment |
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Experimental: Angiotensin-(1-7)
Patients will receive an intravenous infusion of five ascending doses of Angiotensin-(1-7). The doses are: 1, 2, 4, 8 and 16 ng/kg/min. Each dose will be maintained for 10 minutes, for a total of 50 minutes.
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Drug: Angiotensin-(1-7)
This is a biologically active endogenous angiotensin peptide. It may play an important role in the regulation of blood pressure by dilating blood vessels.
Other Names:
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Placebo Comparator: Saline
Patients will receive an intravenous infusion of saline that is matched in volume to the Angiotensin-(1-7) study day. The saline infusion will be maintained for 50 minutes.
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Drug: Saline
Normal saline will be used as the placebo comparator.
Other Names:
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- Blood Pressure [ Time Frame: 50 minutes ]The decrease in blood pressure following angiotensin-(1-7) versus saline infusion.
- Heart Rate [ Time Frame: 50 minutes ]The change in heart rate following angiotensin-(1-7) versus saline infusion.
- Cardiac Output [ Time Frame: 50 minutes ]The change in cardiac output following angiotensin-(1-7) versus saline infusion.
- Stroke Volume [ Time Frame: 50 minutes ]The change in stroke volume following angiotensin-(1-7) versus saline infusion.
- Systemic Vascular Resistance [ Time Frame: 50 minutes ]The change in systemic vascular resistance following angiotensin-(1-7) versus saline infusion.
- Renin Activity [ Time Frame: 50 minutes ]The change in plasma renin activity following angiotensin-(1-7) versus placebo infusion.
- Angiotensin Peptides [ Time Frame: 50 minutes ]The change in plasma angiotensin peptides following angiotensin-(1-7) versus placebo infusion.
- Aldosterone [ Time Frame: 50 minutes ]The change in plasma aldosterone following angiotensin-(1-7) versus placebo infusion.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females of all races between 18 to 80 years of age.
- Diagnosed with primary autonomic failure and supine hypertension. Supine hypertension will be defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg while lying down.
- Able and willing to provide informed consent.
Exclusion Criteria:
- Pregnancy or breast feeding.
- Hemoglobin < 10.5 or hematocrit < 32.
- High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, renal failure, history of stroke or myocardial infarction).
- Inability to give or withdraw informed consent.
- Other factors which in the investigator's opinion would prevent the patient from completing the protocol (e.g. clinically significant abnormalities on clinical, mental examination, or laboratory testing or inability to comply with the protocol).

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): NCT02591173
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37211 |
Principal Investigator: | Italo Biaggioni, MD | Vanderbilt University Medical Center |
Responsible Party: | Italo Biaggioni, Professor, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT02591173 |
Other Study ID Numbers: |
151461 |
First Posted: | October 29, 2015 Key Record Dates |
Last Update Posted: | January 12, 2021 |
Last Verified: | January 2021 |
Autonomic Hypertension Renin-Angiotensin System |
Hypotension, Orthostatic Pure Autonomic Failure Nervous System Diseases Shy-Drager Syndrome Multiple System Atrophy Autonomic Nervous System Diseases Primary Dysautonomias Hypotension Vascular Diseases Cardiovascular Diseases Orthostatic Intolerance Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases Angiotensin I (1-7) Angiotensin II Angiotensinogen Antihypertensive Agents Vasodilator Agents Vasoconstrictor Agents Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |