Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure - Full Text View

Sponsored by:	ResMed
Information provided by:	ResMed
ClinicalTrials.gov Identifier:	NCT00733343

Purpose

The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnoea. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. It is assumed that the hazard rate is constant over time.

Condition	Intervention	Phase
Heart Failure Sleep Disordered Breathing	Device: Europe: AutoSet CS 2, USA: VPAP Adapt SV	Phase III

Genetics Home Reference related topics: congenital central hypoventilation syndrome

MedlinePlus related topics: Heart Failure Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure

Further study details as provided by ResMed:

Primary Outcome Measures:

1) all cause mortality or unplanned hospitalization for worsening heart failure [ Time Frame: time to first event ] [ Designated as safety issue: No ]
2) cardiovascular mortality or unplanned hospitalization for worsening heart failure [ Time Frame: time to first event ] [ Designated as safety issue: No ]
3) all cause mortality or all cause hospitalization [ Time Frame: time to first event ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time until death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Time until non-cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Time until cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Time until unplanned hospitalization due to worsening of heart failure or cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Time until unplanned hospitalization for other reasons or death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Time until unplanned hospitalization for cardiovascular cause or cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Time to first adequate shock in patients with ICD (evaluation of appropriateness will also be made by the ERC) or cardiovascular death [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Percent of follow up days which patient survives and is not hospitalized for cardiovascular cause [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Percent of follow up days which patient survives and is not hospitalized for other reasons [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Changes in NYHA classification as compared to baseline [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Difference in health costs between the two treatment groups [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Changes in QoL (Minnesota) as compared to baseline [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Changes in renal function (based on serum creatinine) as compared to baseline [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Changes in Six Minute Walking Distance (6MWD) (50) as compared to baseline [ Time Frame: the last follow up or at the last available observation within FU ] [ Designated as safety issue: No ]
Number and cost of hospitalisations (with tariff/DRG, diagnoses and procedures for calculating DRG or length of stay and level of care provided) [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Cost of care (technology and service, nursing, physicians visit) related to ventilation [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Difference in utilities / QoL (Minnesota and EQ5D) compared to control arm [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Difference in cost of resources consumed [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Cost-efficacy [ Time Frame: End of the study ] [ Designated as safety issue: No ]
Cost-utility [ Time Frame: End of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	1260
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Group: Active Comparator treatment with Adaptive Servoventilation + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)	Device: Europe: AutoSet CS 2, USA: VPAP Adapt SV At least 3 hours average daily usage time
Control Group: No Intervention standard medical therapy according to applicable guidelines (ESC, ACC/AHA)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be at least 18 years old
Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC, ACC/AHA)
Left ventricular systolic dysfunction (LVEF <40% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for HF in the last 12 months
No hospitalisation for heart failure for at least 4 weeks prior to inclusion
Optimised medical treatment according to applicable guidelines with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE inhibitors/ ARB antagonists the reasons must be documented
SDB (AHI > 15/h with ≥ 50% central events and a central AHI ≥ 10/h, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
Patient is able to fully understand study information and signed informed consent

Exclusion Criteria:

Significant COPD with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation
Oxygen saturation at rest during the day ≤ 90% at inclusion
Current use of Positive Airway Pressure (PAP) - therapy
Life expectancy < 1 year for diseases unrelated to chronic HF
Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
CRT-implantation or ICD-implantation scheduled or within 6 months prior to randomisation
Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
Acute myocarditis/pericarditis within 6 months prior to randomisation
Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in Appendix IX at the time of study entry
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733343

Contacts

Contact: Andrea Ballentin, MD	+49 89 54 88 44 255	serve-hf@ikkf.de
Contact: Simone Knabl	+49 89 54 88 44 274	serve-hf@ikkf.de

Show 90 Study Locations

Sponsors and Collaborators

ResMed

Investigators

Principal Investigator:	Helmut Teschler, Prof	Universitaetsklinik Essen
Principal Investigator:	Martin Cowie, Prof	National Heart and Lung Institute (NHLI) Brompton Hospital, London

More Information

No publications provided

Responsible Party:	ResMed GmbH & Co. KG ( Holger Woehrle )
Study ID Numbers:	01, ISRCTN19572887
Study First Received:	February 14, 2008
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00733343
Health Authority:	Germany: Ethics Commission; France: Afssaps - French Health Products Safety Agency; United Kingdom: National Health Service; Norway: The National Committees for Research Ethics in Norway; Sweden: Regional Ethical Review Board; United States: Food and Drug Administration

Keywords provided by ResMed:

heart failure
sleep disordered breathing
sleep apnea

left ventricular systolic dysfunction
SBAS
HF

Study placed in the following topic categories:

Heart Failure
Sleep Apnea Syndromes
Heart Diseases
Respiratory Tract Diseases
Apnea

Sleep Apnea, Central
Respiration Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2009