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Sponsored by: |
ResMed |
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Information provided by: | ResMed |
ClinicalTrials.gov Identifier: | NCT00733343 |
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 |
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Heart Failure Sleep Disordered Breathing |
Device: Europe: AutoSet CS 2, USA: VPAP Adapt SV |
Phase III |
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 |
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 |
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Treatment Group: Active Comparator
treatment with Adaptive Servoventilation + standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
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Device: Europe: AutoSet CS 2, USA: VPAP Adapt SV
At least 3 hours average daily usage time
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Control Group: No Intervention
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Helmut Teschler, Prof | Universitaetsklinik Essen |
Principal Investigator: | Martin Cowie, Prof | National Heart and Lung Institute (NHLI) Brompton Hospital, London |
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 |
heart failure sleep disordered breathing sleep apnea |
left ventricular systolic dysfunction SBAS HF |
Heart Failure Sleep Apnea Syndromes Heart Diseases Respiratory Tract Diseases Apnea |
Sleep Apnea, Central Respiration Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Nervous System Diseases Cardiovascular Diseases |