Clinical trial NCT01414309: Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea
Official title: Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Central Sleep Apnea
Heart Failure
Keywords: Heart Failure
Central Sleep Apnea
Sleep Disordered Breathing
Cardiac Dysfunction
Lead sponsor: Respicardia, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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 progression of moderate to severe CSA in heart failure patients.

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Apnea-hypopnea index and its components
timeFrame: 6 months
Secondary outcomes:
measure: Clinical status associated with sleep disordered breathing
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: St Cloud
country: United States
facility: Central MN Heart at St Cloud
state: Minnesota
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center, Alamo
state: Texas
city: Berlin
country: Germany
facility: Charite, Campus Virchow-Klinikum
Study officials:
affiliation: Respicardia, Inc.
name: Robin Germany, M.D.
role: STUDY_DIRECTOR
References: