Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060866
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-05-14
Brief Title:
Propranolol to Treat Fainting Due to 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
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
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 patients 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 inserted into a vein in each arm one to collect venous deoxygenated blood samples and the other to inject radioactive epinephrine adrenaline and norepinephrine noradrenaline These radioactive drugs or tracers allow measurement of the rate of release of the bodys own norepinephrine and epinephrine into the bloodstream
Physiologic measurements Blood pressure heart rate and 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 fingers or other sites
The effects of the test drug are allowed to wear off for 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
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 patients 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 inserted into a vein in each arm one to collect venous deoxygenated blood samples and the other to inject radioactive epinephrine adrenaline and norepinephrine noradrenaline These radioactive drugs or tracers allow measurement of the rate of release of the bodys own norepinephrine and epinephrine into the bloodstream
Physiologic measurements Blood pressure heart rate and 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 fingers or other sites
The effects of the test drug are allowed to wear off for 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:
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 SAI plasma epinephrine levels increase progressively and to a greater extent than do plasma norepinephrine levels before development of NCS The SAI pattern is associated with skeletal muscle vasodilation which also precedes NCS We hypothesize that increased occupation of beta-2 adrenoceptors in skeletal muscle by high circulating epinephrine levels precipitates a neurocirculatory positive feedback loop leading to NCS In this protocol we test this hypothesis 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 in a randomized crossover-design placebo-controlled double-blind trial The main department measures are occurrence of tilt-induced NCS duration of tilt tolerance hemodynamic and neurochemical indices of SAL 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 |
|---|---|---|---|
| 03-N-0182 | None | None | None |