Bilevel Positive Pressure Ventilation (BIPAP)in Patients With Sleep Disorders Breathing (SDB)and Congestive Heart Failure (CHF):Comparison of Two Diagnostic Methods
Primary Purpose
Symptomatic Congestive Heart Failure
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
watch-pat
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Congestive Heart Failure focused on measuring CHF, watch-pat, embletta x, endothelial function
Eligibility 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.
Sites / Locations
- Meir Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
all patients with symptomatic CHF
Arm Description
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.
Outcomes
Primary Outcome Measures
changes in frequency of centeral sleep apnea in patients with congestive heart failure before and after BIPAP treatment
Secondary Outcome Measures
changes in ejection fraction measured by cardiac echocardiography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01501734
Brief Title
Bilevel Positive Pressure Ventilation (BIPAP)in Patients With Sleep Disorders Breathing (SDB)and Congestive Heart Failure (CHF):Comparison of Two Diagnostic Methods
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Congestive Heart Failure
Keywords
CHF, watch-pat, embletta x, endothelial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
all patients with symptomatic CHF
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
watch-pat
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in frequency of centeral sleep apnea in patients with congestive heart failure before and after BIPAP treatment
Time Frame
4 months
Secondary Outcome Measure Information:
Title
changes in ejection fraction measured by cardiac echocardiography
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
alex guver
Phone
09-7471556
12. IPD Sharing Statement
Learn more about this trial
Bilevel Positive Pressure Ventilation (BIPAP)in Patients With Sleep Disorders Breathing (SDB)and Congestive Heart Failure (CHF):Comparison of Two Diagnostic Methods
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