Effects of CPAP on Ventricular Function Modifications
Primary Purpose
Heart Failure, Congestive
Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CPAP (Continuous Positive Airway Pressure)
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure, Congestive focused on measuring Heart Failure, Congestive, Continuous Positive Airway Pressure, Baroreflex, Echocardiography
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of heart failure
- Chronic heart failure
- Ejection fraction < 40%
Exclusion Criteria:
- Age < 18 years
- Permanent atrial fibrillation
- Infiltrative cardiomyopathy
- Mild/moderate chronic obstructive lung disease
- Chronic heart failure
- Diabetes mellitus
- Chronic kidney failure
Sites / Locations
- Ospedale San Giovanni Bosco Medicina d'Urgenza
Outcomes
Primary Outcome Measures
Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration
Secondary Outcome Measures
Full Information
NCT ID
NCT00455611
First Posted
April 2, 2007
Last Updated
March 7, 2013
Sponsor
Ospedale S. Giovanni Bosco
1. Study Identification
Unique Protocol Identification Number
NCT00455611
Brief Title
Effects of CPAP on Ventricular Function Modifications
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled in the study
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ospedale S. Giovanni Bosco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Heart Failure, Congestive, Continuous Positive Airway Pressure, Baroreflex, Echocardiography
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CPAP (Continuous Positive Airway Pressure)
Primary Outcome Measure Information:
Title
Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of heart failure
Chronic heart failure
Ejection fraction < 40%
Exclusion Criteria:
Age < 18 years
Permanent atrial fibrillation
Infiltrative cardiomyopathy
Mild/moderate chronic obstructive lung disease
Chronic heart failure
Diabetes mellitus
Chronic kidney failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Olliveri, MD
Organizational Affiliation
ospedale San Giovanni Bosco ASL4
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale San Giovanni Bosco Medicina d'Urgenza
City
Torino
State/Province
Piedmont
ZIP/Postal Code
10154
Country
Italy
12. IPD Sharing Statement
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Effects of CPAP on Ventricular Function Modifications
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