Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455611
Status:
WITHDRAWN
Last Update Posted:
2013-03-08
First Post:
2007-04-02
Brief Title:
Effects of CPAP on Ventricular Function Modifications
Sponsor:
Ospedale S Giovanni Bosco
Organization:
Ospedale S Giovanni Bosco
Study Overview
Official Title:
Evaluation of the Effects of Intra-thoracic Positive Pressure Applicated With CPAP Continuous Positive Airway Pressure on Ventricular Function in Patients With Chronic Heart Failure Modification Induced on Baroreflex Sensitivity
Status:
WITHDRAWN
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients enrolled in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess modifications of ventricular function induced by CPAP Continuous Positive Airway Pressure
Detailed Description:
There are still few studies on the effects of positive intra-thoracic pressure on ventricular function and spontaneous baroreflex sensitivity changes Aim of the study is to evaluate in patients with chronic heart failure with an ejection fraction 40 the modifications of ventricular function induced by CPAP Continuos Positive Airway Pressure application All the measurament will be made in basal condition without CPAP and with CPAP administration at 10 cmH2O via an oro-nasal mask
Echocardiograpich evaluation morphologic and hemodynamic evaluation is obtained with an echocardiographic exmination Left ventricular measurement will be assessed in M-mode under two dimensional guide according to American Society of Echocardiography guidelines Left ventricular ejection fraction will be assessed with Simpson method
Right ventricle morphology will be evaluated categorizing dimensions in a normal b mild enlargement c severely increased and d reduced Right ventricle area will also be quantified in tele-diastole and in meso-sistole in apical 4 chamber and parasternal short-axis
Baroreflex control of heart rate was assessed by sequence method analysis of continuous blood pressure recordings obtained in basal condition and during CPAP Data obtained by non invasive assessment of arterial pressure will be analized and values of arterial systolic diastolic pressure and pulsatory period for each cardiac cicle will be registered
Assessment via sequence method is founded on identification every 10 minutes on sequences characterized by a progressive increase both in pressure both in RR interval or conversely by a progressive reduction of pressure and RR interval evaluated on 4 or more cardiac cicles
Echocardiograpich evaluation morphologic and hemodynamic evaluation is obtained with an echocardiographic exmination Left ventricular measurement will be assessed in M-mode under two dimensional guide according to American Society of Echocardiography guidelines Left ventricular ejection fraction will be assessed with Simpson method
Right ventricle morphology will be evaluated categorizing dimensions in a normal b mild enlargement c severely increased and d reduced Right ventricle area will also be quantified in tele-diastole and in meso-sistole in apical 4 chamber and parasternal short-axis
Baroreflex control of heart rate was assessed by sequence method analysis of continuous blood pressure recordings obtained in basal condition and during CPAP Data obtained by non invasive assessment of arterial pressure will be analized and values of arterial systolic diastolic pressure and pulsatory period for each cardiac cicle will be registered
Assessment via sequence method is founded on identification every 10 minutes on sequences characterized by a progressive increase both in pressure both in RR interval or conversely by a progressive reduction of pressure and RR interval evaluated on 4 or more cardiac cicles
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