Effects of CPAP on Ventricular Function Modifications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455611
Recruitment Status : Withdrawn (No patients enrolled in the study)
First Posted : April 3, 2007
Last Update Posted : March 8, 2013
Information provided by:
Ospedale S. Giovanni Bosco

Brief Summary:
To assess modifications of ventricular function induced by CPAP (Continuous Positive Airway Pressure).

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Device: CPAP (Continuous Positive Airway Pressure) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : May 2006
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00455611

Ospedale San Giovanni Bosco Medicina d'Urgenza
Torino, Piedmont, Italy, 10154
Sponsors and Collaborators
Ospedale S. Giovanni Bosco
Study Director: Federico Olliveri, MD ospedale San Giovanni Bosco ASL4 Identifier: NCT00455611     History of Changes
Other Study ID Numbers: gbosco4
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: April 2007

Keywords provided by Ospedale S. Giovanni Bosco:
Heart Failure, Congestive
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases