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Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure

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ClinicalTrials.gov Identifier: NCT00725595
Recruitment Status : Unknown
Verified August 2008 by Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : July 30, 2008
Last Update Posted : August 26, 2008
Sponsor:
Information provided by:
Nanjing Medical University

Study Description
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Brief Summary:
The overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. The intent of the proposed intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.

Condition or disease
Heart Failure Sleep Apnea

Study Design
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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Only
Study Start Date : August 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
E, 2, III
To treat CSR with ASV and Bilevel ventilators


Outcome Measures
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Primary Outcome Measures :
  1. Both ASV and Bilevel ventilation are effective in clinical treatment of CSR [ Time Frame: three months ]

Secondary Outcome Measures :
  1. ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure [ Time Frame: three months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with both CSR and heart failure
Criteria

Inclusion Criteria:

  1. Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States
  2. Subject is > 18 years old

  3. Patients with known history of CSR. CSR symptoms may include the following:

    • sleep fragmentation as reported by patient or as witnessed by another person
    • night arousal after apneic episodes
    • reduced exercise capacity
    • daytime sleepiness
  4. Expected to tolerate the ventilator therapy

Exclusion Criteria:

  1. Baseline oxygen saturation < 90% on a stable FIO2)
  2. Patient is currently enrolled in another clinical study which may confound the results of this study
  3. Patient for whom informed consent cannot be obtained
  4. Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
  5. Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency)
  6. Patients with severe COPD (per GOLD scale)
  7. Patients with a history of myocardial infarction within the 6 months prior to the study
  8. Patients with unstable angina
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00725595


Contacts
Contact: Zhang Xilong, PhD 96-25-83714511 ext 6723 zhangxilong1952@yahoo.com.cn

Locations
China, Jiangsu
The 1st Affiliated Hospitak of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Wang Hong, PhD    86-83714511 ext 6705    zhsj_wh@hotmail.com   
Principal Investigator: Zhang Shijiang, MD         
Principal Investigator: Zhang Xilong, MD         
Sub-Investigator: Wang Hong, MD         
Sponsors and Collaborators
Nanjing Medical University
More Information
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Additional Information:
CSR and heart failure  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Glenn Richard, ResMed Inc. of Australia
ClinicalTrials.gov Identifier: NCT00725595     History of Changes
Other Study ID Numbers: 092801
20070928
No 092801
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: August 26, 2008
Last Verified: August 2008

Keywords provided by Nanjing Medical University:
Cheyne Stocks respiration
heart failure
sleep apnea
ventilator

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