The Role of Endothelin in the Supine Hypertension of Autonomic Failure

NCT01119417 | Withdrawn Phase 1

• 1 other identifier: 091344
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the hypothesis that endothelin plays a role in the pathogenesis of supine hypertension in pure autonomic failure by increasing vascular resistance. To gauge its contribution to blood pressure regulation, pure autonomic failure and multiple system atrophy patients with supine hypertension will undergo a medication testing with the endothelin blocker, BQ123. We will compare the hemodynamic effects between PAF and MSA patients. Our primary endpoint will be the decrease in blood pressure during the administration of this compound.

Conditions

Hypertension; Pure Autonomic Failure; Multiple System Atrophy

Keywords

supine Hypertension; autonomic failure; BQ123; BQ-123; endothelin

Outcome Measures

Primary Outcomes (1)

• Change in Systolic BP

  Change from baseline in systolic blood pressure

  0 -4 hr post infusion

Secondary Outcomes (1)

• Change in cardiac output, stroke volume and systemic vascular resistance

  0-4 hr post infusion

Study Arms (2)

BQ123

EXPERIMENTAL

endothelin blocker

Drug: BQ123

Saline

PLACEBO COMPARATOR

IV saline

Drug: Saline

Interventions

BQ123 DRUG

Low dose day: 25 nmol/min, single IV infusion for 15 min.

Also known as: BQ-123 sodium salt

BQ123

Saline DRUG

2-3 IV saline infusions for 15 min each.

Also known as: Normal saline, 0.9% sodium chloride

Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with autonomic failure and supine hypertension from all races, who are in the hospital participating in the study "The Evaluation and Treatment of Autonomic Failure" (IRB# 000814).
• Supine hypertension, defined as a systolic blood pressure \>150 mm Hg or diastolic blood pressure \> 90 mm Hg.
• Males and females, between 18-85yr.
• Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.

You may not qualify if:

• Pregnant women.
• High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction).
• History of serious allergies or asthma.
• In the investigator's opinion, have clinically significant abnormalities on clinical, mental examination or laboratory testing.
• All medical students.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hypertension; Pure Autonomic Failure; Multiple System Atrophy

Interventions

cyclo(Trp-Asp-Pro-Val-Leu); Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Italo Biaggioni, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 7, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)