Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01414309
Recruitment Status : Terminated (Change in company priorities)
First Posted : August 11, 2011
Last Update Posted : January 7, 2015
Information provided by (Responsible Party):
Respicardia, Inc.

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.

Condition or disease
Central Sleep Apnea Heart Failure

Detailed Description:
This trial is a prospective, non-randomized observational study in heart failure patients with moderate to severe central sleep apnea (CSA).

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea
Study Start Date : August 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Observational patients
Heart Failure patients with moderate to severe central sleep apnea

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Clinical status associated with sleep disordered breathing [ Time Frame: 6 months ]
    • Epworth Sleepiness Scale
    • Subject Global Assessment
    • Quality of life as measured by Minnesota Living with Heart Failure Questionnaire
    • HF Clinical Composite
    • Six-minute hall walk
    • NYHA Functional Class
    • Echocardiographic measures of structure and function
    • Subject medications

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01414309

United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Central MN Heart at St Cloud
St Cloud, Minnesota, United States, 56303
United States, Texas
Sleep Therapy & Research Center, Alamo
San Antonio, Texas, United States, 78229
Charite, Campus Virchow-Klinikum
Berlin, Germany, D-13353
Sponsors and Collaborators
Respicardia, Inc.
Study Director: Robin Germany, M.D. Respicardia, Inc.

Additional Information:
Responsible Party: Respicardia, Inc. Identifier: NCT01414309     History of Changes
Other Study ID Numbers: EP 1137
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015

Keywords provided by Respicardia, Inc.:
Heart Failure
Central Sleep Apnea
Sleep Disordered Breathing
Cardiac Dysfunction

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea Syndromes
Sleep Apnea, Central
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases