Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
Study NCT ID:
NCT03985657
Status:
COMPLETED
Last Update Posted:
2020-12-28
First Post:
2019-06-11
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hemodynamics Response to Upper Airway Obstruction in Marfan Syndrome
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Sleep Disordered Breathing in Marfan Syndrome: Susceptibility and Hemodynamics
Status:
COMPLETED
Status Verified Date:
2020-12
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:
MSB
Brief Summary:
Upper airway obstruction (UAO) is an unrecognized source of hemodynamic stress that may contribute to aortic adverse events in persons with Marfan Syndrome (MFS). UAO occurs during snoring and sleep apnea and is characterized by repetitive partial or complete obstruction of the upper airway during sleep. These obstructive breathing events lead to intermittent surges in blood pressure (BP) REF and large decreases in pleural pressure (Pes), thereby increasing the trans-mural aortic pressure (TMP) and imposing mechanical stress on the aorta during sleep. Although UAO is known to increase mechanical stress on the aorta, the magnitude of the increase is not known for persons with MFS.
In this project, therefore, the investigators will also examine the changes in Pes and BP responses in periods of obstructed breathing and compare the diurnal markers or vascular stress between Baseline and CPAP studies in MFS persons.
In this project, therefore, the investigators will also examine the changes in Pes and BP responses in periods of obstructed breathing and compare the diurnal markers or vascular stress between Baseline and CPAP studies in MFS persons.
Detailed Description:
Research Objective/Significance:
Specific Aim 1a: To quantify the Pes and BP during periods with and without UAO during sleep in persons with MFS.
Specific Aim 1b: To examine the effect of CPAP treatment of UAO on Pes and BP in MFS persons.
Specific Aim 2: To examine the effect of CPAP treatment of UAO on daytime markers of hemodynamic stress (augmentation index, reactive hyperemia index) in MFS persons.
Primary Outcomes:
* Overnight measure of hemodynamic stress (blood pressure, pleural pressure swings)
Secondary Outcomes:
* Changes in diurnal markers of hemodynamic stress (augmentation index, reactive hyperemia index)
Specific Aim 1a: To quantify the Pes and BP during periods with and without UAO during sleep in persons with MFS.
Specific Aim 1b: To examine the effect of CPAP treatment of UAO on Pes and BP in MFS persons.
Specific Aim 2: To examine the effect of CPAP treatment of UAO on daytime markers of hemodynamic stress (augmentation index, reactive hyperemia index) in MFS persons.
Primary Outcomes:
* Overnight measure of hemodynamic stress (blood pressure, pleural pressure swings)
Secondary Outcomes:
* Changes in diurnal markers of hemodynamic stress (augmentation index, reactive hyperemia index)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: