Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093860
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-10-06
Brief Title:
Propranolol to Treat Fainting in Children With Sympathoadrenal Imbalance
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Propranolol for Syncope With Sympathoadrenal Imbalance in Children
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Children between 10 and 17 years of age with frequent fainting or near-fainting due to SAI may be eligible for this study Children must experience severe dizzy episodes at least once every 2 months or fainting episodes at least once every 4 months The condition must be severe enough to affect the childs quality of life or to have forced the child to alter his or her life routines to accommodate to the illness Screening includes a tilt table test described below to determine if the child has a particular chemical pattern in the blood
Children 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 children are randomly assigned to take either propranolol or placebo a look-alike pill with no active ingredient for a maximum of 3 days On the fourth day the child undergoes a tilt table test to determine whether the treatment affects his or her ability to tolerate tilt For this test the child lies on a padded table with a motorized tilt mechanism that can move the child from a flat position to an upright position in about 10 seconds The child remains upright for up to 40 minutes while the following measurements are taken
Blood sampling Blood is drawn through a catheter thin plastic tube placed in an arm vein This allows repeated sampling without repeated needle sticks Samples are collected before starting the tilt test about every 4 minutes during the test immediately when a drop in blood pressure is detected or symptoms develop and after 10 minutes of recovery lying flat A maximum of 12 samples are collected for each tilt test
Physiologic measurements Blood pressure heart rate and electrocardiogram EKG are measured continuously during the tilt test session and blood flows and skin electrical conduction are measured intermittently Blood flow is measured using sensors applied to the skin and a blood pressure cuff around the limb For skin blood flow measurements a laser beam scans the skin surface The skin electrical conduction test measures how well the skin conducts electricity This is measured through sensors placed on the tips of two fingers Respiration and breathing rate are monitored by an elastic cloth band around the chest
Self-report questionnaires Patients or their parents complete a questionnaire about the childs symptoms before and during treatment
The effects of the test drug are allowed to wear off for up to 1 week after which the entire tilt test procedure is repeated Patients who were given propranolol for the first test session take placebo for the repeat session and those who were given placebo take propranolol
Children between 10 and 17 years of age with frequent fainting or near-fainting due to SAI may be eligible for this study Children must experience severe dizzy episodes at least once every 2 months or fainting episodes at least once every 4 months The condition must be severe enough to affect the childs quality of life or to have forced the child to alter his or her life routines to accommodate to the illness Screening includes a tilt table test described below to determine if the child has a particular chemical pattern in the blood
Children 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 children are randomly assigned to take either propranolol or placebo a look-alike pill with no active ingredient for a maximum of 3 days On the fourth day the child undergoes a tilt table test to determine whether the treatment affects his or her ability to tolerate tilt For this test the child lies on a padded table with a motorized tilt mechanism that can move the child from a flat position to an upright position in about 10 seconds The child remains upright for up to 40 minutes while the following measurements are taken
Blood sampling Blood is drawn through a catheter thin plastic tube placed in an arm vein This allows repeated sampling without repeated needle sticks Samples are collected before starting the tilt test about every 4 minutes during the test immediately when a drop in blood pressure is detected or symptoms develop and after 10 minutes of recovery lying flat A maximum of 12 samples are collected for each tilt test
Physiologic measurements Blood pressure heart rate and electrocardiogram EKG are measured continuously during the tilt test session and blood flows and skin electrical conduction are measured intermittently Blood flow is measured using sensors applied to the skin and a blood pressure cuff around the limb For skin blood flow measurements a laser beam scans the skin surface The skin electrical conduction test measures how well the skin conducts electricity This is measured through sensors placed on the tips of two fingers Respiration and breathing rate are monitored by an elastic cloth band around the chest
Self-report questionnaires Patients or their parents complete a questionnaire about the childs symptoms before and during treatment
The effects of the test drug are allowed to wear off for up to 1 week after which the entire tilt test procedure is repeated Patients who were given propranolol for the first test session take placebo for the repeat session and those who were given placebo take propranolol
Detailed Description:
Objectives This protocol is to evaluate treatment with oral propranolol for a particular form of neurocardiogenic syncope NCS characterized by a neuroendocrine pattern called sympathoadrenal imbalance SAI in children In SAI plasma adrenaline levels increase progressively and to a greater extent than do norepinephrine levels before syncope The SAI pattern is associated with skeletal muscle vasodilation We hypothesize that increased occupation of beta-2 adrenoceptors in skeletal muscle by high circulating adrenaline levels precipitates the neurocirculatory positive feedback loop that leads to NCS
Study Population Patients 10-17 years old with a history of NCS
Design In a randomized crossover-design placebo-controlled double-blind trial we test the above hypothesis by using the non-selective beta-adrenoceptor blocker propranolol We predict that in patients with previously documented SAI and tilt-evoked NCS propranolol treatment will improve orthostatic tolerance during follow-up tilt table testing
Outcome Measures The primary outcome measure will be whether propranolol therapy can prevent tilt induced syncope or significant hypotension andor bradycardia preceding development of clinical symptoms greater than or equal to 20 mm Hg decrease in blood pressure or heart rate less than 40 beatsmin Secondary dependent measures that will be assessed are occurrence of duration of tilt tolerance if tilt induced symptoms are provoked hemodynamic and neurochemical indices of SAI and patient questionnaire reports
Study Population Patients 10-17 years old with a history of NCS
Design In a randomized crossover-design placebo-controlled double-blind trial we test the above hypothesis by using the non-selective beta-adrenoceptor blocker propranolol We predict that in patients with previously documented SAI and tilt-evoked NCS propranolol treatment will improve orthostatic tolerance during follow-up tilt table testing
Outcome Measures The primary outcome measure will be whether propranolol therapy can prevent tilt induced syncope or significant hypotension andor bradycardia preceding development of clinical symptoms greater than or equal to 20 mm Hg decrease in blood pressure or heart rate less than 40 beatsmin Secondary dependent measures that will be assessed are occurrence of duration of tilt tolerance if tilt induced symptoms are provoked hemodynamic and neurochemical indices of SAI and patient questionnaire reports
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-N-0001 | None | None | None |