- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00804349
Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients (ARIA-II)
Apnea Rampant In Acute Decompensated Heart Failure II
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.
|
|
Active Comparator: Autotitrating Positive Airway Pressure
Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.
|
Patients will be treated with Autotitrating Positive Airway Pressure therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in Episodic Oxygen Desaturation
Time Frame: Concurrent
|
0 participants analyzed.
Study closed; PI no longer at the institution.
Efforts to have the PI add the required information have been unsuccessful.
No study data are available.
|
Concurrent
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission
Time Frame: 30 days post discharge
|
0 participants analyzed.
Study closed; PI no longer at the institution.
Efforts to have the PI add the required information have been unsuccessful.
No study data are available.
|
30 days post discharge
|
Length of Stay
Time Frame: Concurrent
|
0 participants analyzed.
Study closed; PI no longer at the institution.
Efforts to have the PI add the required information have been unsuccessful.
No study data are available.
|
Concurrent
|
Visual Analog Scale of Shortness of Breath
Time Frame: Concurrent
|
0 participants analyzed.
Study closed; PI no longer at the institution.
Efforts to have the PI add the required information have been unsuccessful.
No study data are available.
|
Concurrent
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Darshak Karia, MD, Albert Einstein Medical Center. Albert Einstein Healthcare Network
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN-3025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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