Status:
COMPLETED
Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients
Lead Sponsor:
Albert Einstein Healthcare Network
Collaborating Sponsors:
Nexan Inc
Conditions:
Heart Failure
Sleep Apnea Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Heart Failure affects 5-6 million Americans and there are about 550 thousand new cases of heart failure every year. There are approximately 3 million hospital admission for acute decompensated heart f...
Detailed Description
Background: Heart failure (HF) affects 5 to 6 million Americans and is increasing in prevalence. There are about 550,000 new cases of heart failure every year and about 3 million admissions for acute...
Eligibility Criteria
Inclusion
- Patients over the age of 18 and able to consent
- NYHA Class III/IV Symptoms
- Objective Evidence of Heart Failure
- Physical Exam consistent with Heart Failure
- BNP greater than 500
- Radiographic Evidence of Heart Failure
- SDB (AHI \> 5/hour) on Nexan CPS
- Ability to tolerate appropriate medical therapy for Heart Failure
- Willingness to follow-up as an outpatient after discharge
Exclusion
- Patients with known Sleep-Disordered Breathing currently using CPAP or BiPAP
- Patients with known COPD
- Patients with known restrictive lung disease
- Patients with tracheostomy in place
- Acute MI/Acute Coronary Syndrome at time of hospitalization
- Cardiogenic Shock
- Troponin Leak greater than 0.08
- Patients with major multisystem disorders
- Expected survival less than 6 months
- End Stage Renal Disease on Dialysis
- Chronic Liver Disease
- Albumin level less than 3.
- Patients from Nursing homes
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00804349
Start Date
October 1 2008
End Date
October 1 2011
Last Update
March 9 2020
Active Locations (1)
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1
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141