Bilevel Positive Pressure Ventilation (BIPAP)in Patients With Sleep Disorders Breathing (SDB)and Congestive Heart Failure (CHF):Comparison of Two Diagnostic Methods

Successful treatment of pulmonary edema was first published in 1938 by A. L. Barach. Since then, this has been the accepted method of treating acute respiratory failure due to left heart failure and edema.

The question was raised if pressure supported ventilation during sleep is used to eliminate sleep apneas, would it be useful also for improving congestive heart failure (CHF). Recent studies assessed the role of continuous positive airway pressure (CPAP) in patients with advanced CHF and found the treatment useful. A possible explanation for these results is that central sleep apnea frequently coexists with severe CHF and is not treated or suppressed by CPAP.

The frequency of central sleep apnea increases with the severity of CHF and can be found in more than 30% of patients.

A few recent studies showed the usefulness of bilevel positive airway pressure (BIPAP) or adaptive servo-ventilation (ASV). ASV led to improvement in ejection fraction as well as in 6 min walking distance testing, and was associated with decreased BNP levels. In another study, bilevel PAP increased LVEF by 7.9%.

The limitations of these studies are the small number of patients and that they were conducted on inpatients only. These factors make it difficult to include BIPAP in the guidelines for chronic heart failure therapy.

Recently, two outpatient modalities have been introduced to diagnose sleep disordering breathing (SDB). However, no study has directly compared the results of both studies in patients with CHF. Moreover, no studies have assessed improvement in CHF after BIPAP treatment.

In addition, the investigators plan to assess the endothelial function in this population before and after BIPAP treatment with the EndoPAT, a noninvasive technology

Study Overview

• Status: Unknown
• Conditions: Symptomatic Congestive Heart Failure
• Intervention / Treatment: Device: watch-pat

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: alex guver; Phone Number: 09-7471556

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years
• Patients that will be able to sign an informed consent
• Able to use BIPAP equipment
• Established diagnosis of congestive heart failure

Exclusion Criteria:

• Patients who cannot acquire BIPAP from the health care system or who are unable to use the BIPAP.
• Patients who will be not able to visit the clinic for follow up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: all patients with symptomatic CHF; Single arm prospective study; Study population will include all patients referred to our outpatient clinic for congestive heart failure for a two-year period, who will be screened for sleep apnea and found to have sleep disordering breathing (SDB).; 200 patients will visit the outpatient clinic for congestive heart failure.; Approximately 30% will be eligible for this study.

Device: watch-pat; The Watch-PAT is a home sleep testing (HST) device. The Watch-PAT is a patient-worn, self-contained, non-invasive device used in the patient's home. The Watch-PAT diagnoses obstructive sleep apnea (OSA) by measuring the PAT signal, heart rate, oxygen saturation, and actigraphy. The PAT signal is a validated surrogate measure of sympathetic activation that is associated with apneic events and respiratory effort related arousals (RERA). The Watch-PAT provides measures of all the OSA indices, i.e., Apnea Hypopnea Index (AHI), Respiratory Disturbances Index (RDI), and Oxygen Desaturation Index (ODI), which enable accurate assessment of the presence and severity of OSA and its effect on sleep architecture, sleep quality. Based on the PAT and actigraphy signals, Watch-PAT differentiates between sleep and wake and detects sleep stages (light, deep, and REM) providing, the effect on additional specific conditions such as REM related apnea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in frequency of centeral sleep apnea in patients with congestive heart failure before and after BIPAP treatment	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
changes in ejection fraction measured by cardiac echocardiography	4 months

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): January 1, 2016
• Study Completion (ANTICIPATED): January 1, 2016

Study Registration Dates

• First Submitted: December 26, 2011
• First Submitted That Met QC Criteria: December 28, 2011
• First Posted (ESTIMATE): December 29, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 12, 2015
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: CHF; endothelial function; watch-pat; embletta x
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 0058-11-MMC