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NCT00060866 · ClinicalTrials.gov registry record · Phase 4
Propranolol to Treat Fainting Due to Sympathoadrenal Imbalance
A Phase 4 study of Neurocardiogenic Syncope, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00060866 is a Phase 4 study of Neurocardiogenic Syncope that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00060866, a Phase 4 study of Neurocardiogenic Syncope, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the effectiveness of the drug propranolol in preventing fainting in patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system and chemical responses in which the blood vessels in skeletal muscles do not remain constricted appropriately during standing for a long time. This can lower blood pressure and cause fainting. Propranolol Inderal (registered trademark) is a Food and Drug Administration-approved drug that belongs to a class of drugs called beta-blockers. These drugs slow the heart rate and maintain blood pressure in certain situations. Patients 18 years of age and older with SAI may be eligible for this study. Screening includes a tilt table test, described below, to determine if the patient has a particular chemical pattern in the blood. Patients enrolled in the study take propranolol pills in increasing doses during the first week of the study to determine the proper dose for the individual. Then, the drug is stopped until the experimental phase of the study begins. In this phase, patients are randomly assigned to take either propranolol or placebo (look-alike pill with no active ingredient) for 4 days. On the fourth day, the patient undergoes a tilt table test to determine whether the treatment affects the patient's ability to tolerate tilt. For this test, the patient lies on a padded table with a motorized tilt mechanism that can move the patient from a flat position to an upright position in about 10 seconds. The patient remains upright for up to 45 minutes while the following measurements are taken: * Arterial blood pressure monitoring and arterial blood sampling. A catheter (thin, plastic tube) is inserted into an artery in the elbow crease area of the arm or the wrist. This catheter allows continuous blood pressure monitoring and sampling of arterial (oxygenated) blood during the tilt test. * Venous blood sampling and measurement of epinephrine and norepinephrine release. A catheter is inser
Conditions Studied
Interventions
- DRUG Propranolol
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2003-05 |
| Est. Completion | 2005-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00060866
The ClinicalTrials.gov registry entry for NCT00060866 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neurocardiogenic Syncope appearing as the primary indexed condition, and to 1 intervention - of which Propranolol is the first listed.
NCT00060866 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00060866 about?
NCT00060866 is a clinical study titled "Propranolol to Treat Fainting Due to Sympathoadrenal Imbalance". This study will examine the effectiveness of the drug propranolol in preventing fainting in patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system and chemical responses in which the blood vessels in skeletal muscles do not remain constricted appropriately durin...
What is the current status of trial NCT00060866?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2003-05. Estimated completion is 2005-03.
What conditions does trial NCT00060866 study?
This clinical trial studies the following conditions: Neurocardiogenic Syncope.
What interventions are being tested in trial NCT00060866?
The interventions under investigation include: Propranolol (DRUG).
Who is sponsoring clinical trial NCT00060866?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00060866 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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