NCT01414309

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 7, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

August 9, 2011

Last Update Submit

January 5, 2015

Conditions

Central Sleep ApneaHeart Failure

Keywords

Heart FailureCentral Sleep ApneaSleep Disordered BreathingCardiac Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea index and its components

    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.

    6 months

Secondary Outcomes (1)

  • Clinical status associated with sleep disordered breathing

    6 months

Study Arms (1)

Observational patients

Heart Failure patients with moderate to severe central sleep apnea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

Central MN Heart at St Cloud

Saint Cloud, Minnesota, 56303, United States

Location

Sleep Therapy & Research Center, Alamo

San Antonio, Texas, 78229, United States

Location

Charite, Campus Virchow-Klinikum

Berlin, D-13353, Germany

Location

Related Links

MeSH Terms

Conditions

Sleep Apnea, CentralHeart FailureSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Robin Germany, M.D.

    Respicardia, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 11, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 7, 2015

Record last verified: 2015-01

Locations

US(3)DE(1)