Phase 4
N=6
Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients
Heart Failure · Sleep Apnea Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00804349 ↗Enrolled (actual)
6
Serious AEs
—
Results posted
Mar 2020
Primary outcome: Primary: Reduction in Episodic Oxygen Desaturation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Autotitrating Positive Airway Pressure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein Healthcare Network
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Episodic Oxygen Desaturation |
— | — |
| SECONDARY Readmission |
— | — |
| SECONDARY Length of Stay |
— | — |
| SECONDARY Visual Analog Scale of Shortness of Breath |
— | — |
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 failure with hospital readmission rate of 20% at 30 days and 50% at 60 day, costing up to 20 billion dollars per year. In our previous study we have discovered that sleep disordered breathing is prevalent in 70% of patients with acute decompensated heart failure. We hypothesize that, detection and treatment of sleep disordered breathing in acute decompensated heart failure patients will reduce episodic hypoxic events during acute decompensation and may decrease hospital length of stay and reduce future readmissions.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00804349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.