Status:
TERMINATED
Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea
Lead Sponsor:
Respicardia, Inc.
Conditions:
Central Sleep Apnea
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs in patients with heart failure (HF). The primary purpose of this study is to document the natural progressio...
Detailed Description
This trial is a prospective, non-randomized observational study in heart failure patients with moderate to severe central sleep apnea (CSA).
Eligibility Criteria
Inclusion
- Subject is willing and able to comply with this protocol and has signed an IRB/MEC approved informed consent (as well as Privacy Protection Authorization in the United States)
- Age is greater than or equal to 18 years
- Known recent history of sleep disordered breathing of predominantly central origin, as evidenced by an overnight PSG with EEG and at least 4 hours of recording that was conducted within 60 days of enrollment and demonstrating the following characteristics:
- AHI greater than or equal to 20
- greater than or equal to 50% of classified events of a central nature
- less than 20% of the total AHI comprised of obstructive apnea events
- Diagnosed chronic heart failure, with medications optimized and stable for at least 30 days prior to the screening PSG, or since the date of the earliest test used for baseline, whichever is longer. Optimal medications include: beta blockade, ACE-I or ARB and diuretics unless contraindicated or not considered medically necessary.
Exclusion
- Current or intended use of any mask-based therapy for central sleep apnea
- Baseline oxygen saturation less than or equal to 90% on a stable FiO2
- Severe Chronic Obstructive Pulmonary Disease (COPD) (per GOLD classification system)
- History of cerebrovascular accident (CVA), myocardial infarction (MI), coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI), or any cardiac ablation procedure within the 3 months prior to the study
- Unstable angina
- History of primary pulmonary hypertension
- Currently enrolled in a non-observational (ie, interventional) clinical study that could confound the results of this study
- If subject has an implanted cardiac resynchronization device (CRT), it must have been implanted at least 3 months before enrollment; any other device must have been implanted at least 30 days prior to enrollment
- Life expectancy of less than 6 months
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01414309
Start Date
August 1 2011
End Date
June 1 2012
Last Update
January 7 2015
Active Locations (4)
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1
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
2
Central MN Heart at St Cloud
Saint Cloud, Minnesota, United States, 56303
3
Sleep Therapy & Research Center, Alamo
San Antonio, Texas, United States, 78229
4
Charite, Campus Virchow-Klinikum
Berlin, Germany, D-13353