Contribution of Angiotensin II to Supine Hypertension in Autonomic Failure

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Hypertension, Pure Autonomic Failure, Multiple System Atrophy

In brief

The purpose of this study is to test the hypothesis that angiotensin II plays a role in the supine hypertension of primary autonomic failure. To determine the contribution of angiotensin II to renin and blood pressure regulation in autonomic failure, patients with multiple system atrophy \[MSA\] or pure autonomic failure \[PAF\] and supine hypertension will undergo medication testing with the angiotensin II receptor blocker losartan. The investigators will compare the biochemical and hemodynamic effects between MSA and PAF patients. In a subset of patients, the investigators will also give the ACE inhibitor captopril. Our primary endpoint will be changes in plasma renin activity, and subsequent components of the circulating renin-angiotensin system, in response to angiotensin II blockade. Our secondary outcome will be changes in hemodynamic measures during administration of these drugs.

Key facts

Study ID

NCT01292694

Run by

Vanderbilt University

People needed

12

Starts

2011-03-01

Expected to finish

2017-03-01

Last updated by the study team

2018-08-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with autonomic failure who exhibit supine hypertension and are in the hospital already participating in the study "The Evaluation and Treatment of Autonomic Failure [IRB # 000814]
• Supine hypertension, defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mm Hg
• Males and females of all races, between 18 to 85 years of age
• Able and willing to provide informed consent with the understanding that they may withdraw consent at any time without prejudice to future medical care

You may not qualify if…

• All medical students
• Pregnant women
• Patients with a history of angioedema
• Patients with a known allergy to any ACE inhibitor or angiotensin receptor blocker
• High-risk patients [e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction]
• Patients with hemoglobin < 10.5 [or hematocrit < 32]
• Inability to give, or withdraw, informed consent
• Other factors which in the investigator's opinion would prevent the patient from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing

Where it is running

• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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