Contribution of Angiotensin II to Supine Hypertension in Autonomic Failure

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01292694
• Date of registration: 08/02/2011
• Prospective Registration: Yes
• Primary sponsor: Vanderbilt University
• Public title: Contribution of Angiotensin II to Supine Hypertension in Autonomic Failure
• Scientific title: Contribution of Angiotensin II to Supine Hypertension in Autonomic Failure
• Date of first enrolment: March 2011
• Target sample size: 12
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01292694
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Italo Biaggioni, MD
• Affiliation: Vanderbilt University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Multiple System Atrophy

Pure Autonomic Failure

Intervention(s)

Drug: Captopril

Drug: Losartan

Drug: Placebo

Primary Outcome(s)

Changes in plasma renin activity and subsequent components of the circulating renin-angiotensin system [Time Frame: 0 - 6 hours post administration]

Secondary Outcome(s)

Changes in blood pressure [Time Frame: 0 - 6 hours post administration]

Changes in heart rate, cardiac output, stroke volume and systemic vascular resistance [Time Frame: 0 - 6 hours post administration]

Secondary ID(s)

101618

Source(s) of Monetary Support

Please refer to primary and secondary sponsors