Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Respicardia, Inc.
ClinicalTrials.gov Identifier:
NCT01414309
First received: August 9, 2011
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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
Central Sleep Apnea
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Respicardia, Inc.:

Primary Outcome Measures:
  • Apnea-hypopnea index and its components [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Clinical status associated with sleep disordered breathing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational patients
Heart Failure patients with moderate to severe central sleep apnea

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414309

Locations
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
Germany
Charite, Campus Virchow-Klinikum
Berlin, Germany, D-13353
Sponsors and Collaborators
Respicardia, Inc.
Investigators
Study Director: Robin Germany, M.D. Respicardia, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Respicardia, Inc.
ClinicalTrials.gov Identifier: NCT01414309     History of Changes
Other Study ID Numbers: EP 1137
Study First Received: August 9, 2011
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014