Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients (NCT00804349) | Clinical Trial Compass
CompletedPhase 4
Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients
United States6 participantsStarted 2008-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.