Clinical trial NCT01501734: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Symptomatic Congestive Heart Failure
Keywords: CHF
watch-pat
embletta x
endothelial function
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: changes in frequency of centeral sleep apnea in patients with congestive heart failure before and after BIPAP treatment
timeFrame: 4 months
Secondary outcomes:
measure: changes in ejection fraction measured by cardiac echocardiography
timeFrame: 4 months
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References: