Effects of CPAP on Ventricular Function Modifications

Heart Failure, Congestive Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00455611
• Other study ID #: gbosco4
• Status: Withdrawn
• Phase: N/A
• First received: April 2, 2007
• Last updated: March 7, 2013
• Start date: May 2006

Study information

• Verified date: April 2007
• Source: Ospedale S. Giovanni Bosco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• CPAP (Continuous Positive Airway Pressure)

Locations

Country	Name	City	State
Italy	Ospedale San Giovanni Bosco Medicina d'Urgenza	Torino	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale S. Giovanni Bosco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of modification of ventricular function and baroreflex sensitivity of heart rate after CPAP administration