Effects of CPAP on Ventricular Function Modifications

NCT ID: NCT00455611

Last Updated: 2013-03-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31

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.

Conditions

Heart Failure, Congestive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

CPAP (Continuous Positive Airway Pressure)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale S. Giovanni Bosco

OTHER

Sponsor Role: lead

Principal Investigators

Federico Olliveri, MD

Role: STUDY_DIRECTOR

ospedale San Giovanni Bosco ASL4

Locations

Ospedale San Giovanni Bosco Medicina d'Urgenza

Turin, Piedmont, Italy

Countries

Italy

Other Identifiers

gbosco4

Identifier Type: -

Identifier Source: org_study_id