Symptomatic Congestive Heart Failure Clinical Trial
| Verified date | August 2012 |
| Source | Meir Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ethics Commission |
| Study type | Interventional |
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
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Meir Medical Center | Kfar Saba |
| Lead Sponsor | Collaborator |
|---|---|
| Meir Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | changes in frequency of centeral sleep apnea in patients with congestive heart failure before and after BIPAP treatment | 4 months | No | |
| Secondary | changes in ejection fraction measured by cardiac echocardiography | 4 months | No |