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The Role of Endothelin in the Supine Hypertension of Autonomic Failure

NCT01119417 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-10-05

No results posted yet for this study

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

Interventions

DRUG

BQ123

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

DRUG

BQ123

Low dose day: 50 nmol/min, single IV infusion for 15 min

DRUG

Bq123

High dose day: 100 nmol/min, single IV infusion for 15 min.

DRUG

BQ123

High dose day: 300 nmol/min, single IV infusion for 15 min.

DRUG

Saline

2-3 IV saline infusions for 15 min each.

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Italo Biaggioni, M.D. · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01119417 on ClinicalTrials.gov