Back to resultsEffect of Adaptive Servoventilation on Cardiac Function in Chronic Heart Failure and Cheyne-Stokes Respiration
Primary Purpose
Chronic Heart Failure, Central Sleep Apnea, Cheyne-Stokes Respiration
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Adaptive servoventilation
Sponsored by
About this trial
This is an interventional trial for Chronic Heart Failure
Eligibility Criteria
Inclusion Criteria:
- chronic heart failure with ejection fraction ≤45%
- optimal medical treatment for at least 1 month
- clinical diagnosis of Cheyne-Stokes respiration
Exclusion Criteria:
- unstable heart failure
- stroke
- transient ischemic attack in last 6 months
- pacemaker, cardioverter-defibrillator or resynchronization device implanted less than 6 months before study entrance
- severe chronic obstructive pulmonary disease
Sites / Locations
- Military Institute of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ASV
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01212705
First Posted
September 30, 2010
Last Updated
September 30, 2010
Sponsor
Military Institute od Medicine National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01212705
Brief Title
Effect of Adaptive Servoventilation on Cardiac Function in Chronic Heart Failure and Cheyne-Stokes Respiration
Official Title
Effect of Adaptive Servoventilation on Cardiac Function, Exercise Tolerance and Quality of Life in Patients With Chronic Heart Failure and Cheyne-Stokes Respiration
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Military Institute od Medicine National Research Institute
4. Oversight
5. Study Description
Brief Summary
Sleep disordered breathing is common in patients with chronic heart failure. Adaptive servoventilation is a novel method of treatment central sleep apnoea, especially associated with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive servoventilation on cardiac function, exercise tolerance and quality of life in patients with chronic heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Central Sleep Apnea, Cheyne-Stokes Respiration
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
ASV
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Adaptive servoventilation
Intervention Description
Background expiratory positive airway pressure with some inspiratory pressure support when needed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
chronic heart failure with ejection fraction ≤45%
optimal medical treatment for at least 1 month
clinical diagnosis of Cheyne-Stokes respiration
Exclusion Criteria:
unstable heart failure
stroke
transient ischemic attack in last 6 months
pacemaker, cardioverter-defibrillator or resynchronization device implanted less than 6 months before study entrance
severe chronic obstructive pulmonary disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Kazimierczak
Phone
48 22 6818017
Email
annakazimierczak@poczta.onet.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Krystian Krzyzanowski
Phone
48 512 356 207
Email
krystian.krzyzanowski@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Kazimierczak
Organizational Affiliation
Military Institute of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military Institute of Medicine
City
Warsaw
State/Province
Szaserow 128
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effect of Adaptive Servoventilation on Cardiac Function in Chronic Heart Failure and Cheyne-Stokes Respiration
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