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Sympathomimetic Agent

Norepinephrine Infusion for Orthostatic Hypertension

Phase 1 & 2
Waitlist Available
Led By Lawrence Latour, Ph.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 experimental days
Awards & highlights
All Individual Drugs Already Approved

Summary

Background: - Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex action of the automatic nervous system makes blood vessels tighten when people stand up. The nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps blood pressure in check. In orthostatic hypotension, the nervous system does not release enough norepinephrine when a person stands up, which can cause fainting or falling. Researchers are interested in determining whether norepinephrine given as a drug by vein can help maintain blood pressure during changes in body position. Objectives: - To determine whether intravenous norepinephrine can maintain blood pressure in people with orthostatic hypotension. Eligibility: - Individuals at least 18 years of age who have been diagnosed with orthostatic hypotension related to Parkinson's disease or pure autonomic failure. Design: * This study will require a 2-day inpatient admission to the NIH Clinical Center. The first day will involve laboratory evaluation and the second day will involve testing with norepinephrine. The second day requires an overnight stay. * Participants will be screened with a medical history and physical examination, blood samples, and an electrocardiogram or echocardiogram. * Participants who are on medications may be asked to taper or discontinue one or more medications for the purposes of this study. Participants may not take aspirin or any drugs that slow blood clotting for 7 days before study participation. * Day 1: Participants will have a clear liquid breakfast, and will have a 1-hour baseline tilt table test to monitor blood flow, skin temperature, sweating, and blood pressure. Body temperature and breathing will also be monitored. * Day 2: Participants will have a clear liquid breakfast, and will have a 2-hour tilt table test. Initial blood pressure readings will be taken, and an intravenous line will be placed. Participants will then receive norepinephrine or saline, followed by additional position changes of the tilt table to measure blood pressure differences before returning to the starting position. After about 10 minutes, the tilt table testing and infusion will be repeated with the other drug (saline or norepinephrine). * Participants will be discharged 24 hours after the testing is complete.

Eligible Conditions
  • Orthostatic Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 experimental days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 experimental days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood Pressure (Diastolic)
Blood Pressure (Mean)
Blood Pressure (Systolic)
Secondary study objectives
Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)
Arterial Plasma Levels of Norepinephrine
Cardiac Output
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: BaselineActive Control1 Intervention
Baseline values measured at various tilt angles, so that each participant may serve as their own control.
Group II: Norepinephrine InfusionActive Control1 Intervention
Subjects were given an norepinephrine infusion at various tilt angles, while measurements were taken.
Group III: Saline infusionPlacebo Group1 Intervention
Subjects received a saline IV infusion as a placebo, while measurements were taken at various tilt angles.

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,381 Previous Clinical Trials
652,213 Total Patients Enrolled
Lawrence Latour, Ph.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
3 Previous Clinical Trials
5,214 Total Patients Enrolled
~0 spots leftby Dec 2025