Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea

Respicardia, Inc.4 sites in 2 countries5 target enrollmentAugust 2011

ConditionsCentral Sleep Apnea Heart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Central Sleep Apnea
Sponsor: Respicardia, Inc.
Enrollment: 5
Locations: 4
Primary Endpoint: Apnea-hypopnea index and its components
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

June 2012

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Respicardia, Inc.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Apnea-hypopnea index and its components

Time Frame: 6 months

The primary objective of the study is to determine the natural progression of central sleep apnea, using the apnea-hypopnea index (AHI) and its components evaluated at 6 months.