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

This study is currently recruiting participants.
Verified August 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01501734
First received: December 26, 2011
Last updated: January 28, 2013
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Symptomatic Congestive Heart Failure
 Device: watch-pat
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • changes in frequency of centeral sleep apnea in patients with congestive heart failure before and after BIPAP treatment [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in ejection fraction measured by cardiac echocardiography [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501734

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: alex guver     09-7471556        
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01501734     History of Changes
Other Study ID Numbers: 0058-11-MMC
Study First Received: December 26, 2011
Last Updated: January 28, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
CHF
watch-pat
embletta x
endothelial function

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013