Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients - NCT00804349-19141 (Clinical Trial 257909)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy257909.aspx
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| City: |
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19141 |
| Conditions: |
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Heart Failure - Sleep Apnea Syndromes |
| Purpose: |
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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.
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| Study summary: |
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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 decompensated heart failure every year. Despite advances in medical care, the hospital
readmission rate is 20% at one month and 50% at six months. The total cost of heart failure
on the health system is upwards of 35 billion dollars per year. About half of these
resources are used during acute hospitalizations.
An important limitation to the current approach to the management of HF is the focus on the
awake patient. This approach underestimates the mechanisms that might contribute to the
pathophysiology or progression of HF.
Sleep disordered breathing (SDB) is very common in congestive heart failure. Recently, the
adverse implications of SDB in patients with HF have been appreciated. Intermittent
apnea-induced hypoxia, hypercapnia, surges in central sympathetic outflow and left
ventricular afterload, daytime hypertension, and loss of vagal heart rate regulation are
potent stimuli to myocyte necrosis and apoptosis, myocardial ischemia, arrhythmias, adverse
cardiac remodeling, and the resulting accelerated disease progression in HF.
This makes us believe that treatment of SDB during acute decompensated heart failure in
addition to standard medical therapy (SMT) would be beneficial.
Study Design:
80 eligible patients admitted to Albert Einstein Medical Center with the diagnosis of
Acutely Decompensated Heart Failure will be recruited for the study. Once patients have been
identified, inclusion and exclusion criteria met, they will be consented to participate in
the trial within 24 to 48 hours of admission to the hospital. After enrollment, the patient
will be screened for SDB with NEXAN CPS system. The Sensor, a flexible data collection patch
that adheres to the patient's chest, continuously records ECG, respiratory, and oximetry
data and allows for future use and evaluation. Patients with SDB will be further randomized
to SDB monitoring only and SDB monitoring plus Autotitratable Continuous Positive Airway
Pressure (APAP) treatment arm. Patients in both arms will be treated with standard of care
therapy for acute heart failure. There is a possibility that patients randomized to APAP
therapy may refuse further treatment after the first night. These patients will be analyzed
on the basis of intention to treat approach
Once randomized, all patients will be fitted with the NEXAN Clear Path System and will
continue to wear it until the time of discharge or 7 days. Those in the treatment group
will be fitted with an Autotitratable Continuous Positive Airway Pressure device and will be
continued on treatment until discharged or a maximum of 7 days.
Follow-up of these patients will include a 15 day and 60 day phone call and a 30 day office
visit. At the 30 day visit the patients will be asked to use the NEXAN sensor for that
night, and return the equipment the next day. The patients that were determined to have
sleep-disordered breathing will be referred for a full overnight polysomnography test. |
| Criteria: |
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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 |
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| Study is available at: |
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Albert Einstein Medical Center
Philadelphia, PA 19141
United States
Primary Contact:
Darshak Karia, MD
Email: kariad@einstein.edu
Phone: 215-456-3291
Secondary Contact:
Darshak Karia, MD
Email: kariad@einstein.edu
Phone: 215-456-3291 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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