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Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure (Serve-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00733343
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
CRI-The Clinical Research Institute GmbH
Information provided by (Responsible Party):
ResMed

Study Description
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Brief Summary:
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 apnea. 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 or disease Intervention/treatment Phase
Heart Failure Sleep Disordered Breathing Device: Europe: AutoSet CS (USA: VPAP Adapt SV) Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure
Study Start Date : February 2008
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure [ Time Frame: time to first event, assessed for up to 70 weeks ]
  2. Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure [ Time Frame: time to first event, assessed for up to 70 weeks ]
  3. All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation [ Time Frame: time to first event, assessed for up to 70 weeks ]

Secondary Outcome Measures :
  1. Death From Any Cause [ Time Frame: the last follow up or at the last available observation within Follow Up (FU), assessed for up to 70 weeks ]
  2. Non-cardiovascular Death [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  3. Cardiovascular Death [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  4. Unplanned Hospitalisation/Prolongation of Hospitalisation Due to Worsening of Heart Failure [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  5. Unplanned Hospitalisation/Prolongation of Hospitalisation for Other Reasons or Death [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  6. Adequate Shock in Patients With ICD (Evaluation of Appropriateness Will Also be Made by the Endpoint Review Committee, ERC), Long-Term Atrial Defibrillator Insertion or Cardiovascular Death [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  7. First Survived Resuscitation for Any Reason (Evaluation Will Also be Made by the ERC) [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  8. First Survived Resuscitation of Sudden Cardiac Arrest (Evaluation Will Also be Made by the ERC) [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  9. Age Baseline [ Time Frame: 1 x at Baseline ]
  10. Body Weight Baseline [ Time Frame: 1 x at baseline ]
  11. Body Mass Index (BMI) Baseline [ Time Frame: 1 x baseline ]
  12. Left Ventricular Ejection Fraction at Baseline [ Time Frame: 1x at baseline ]
  13. Blood Pressure Systolic Baseline [ Time Frame: 1 x at baseline ]
  14. Blood Pressure Diastolic Baseline [ Time Frame: 1 x at baseline ]
  15. Hemoglobine Baseline [ Time Frame: 1 x at baseline ]
  16. Creatinine Baseline [ Time Frame: 1 x at baseline ]
  17. Glomerular Filtration Rate Baseline [ Time Frame: 1 x at baseline ]
  18. 6-Min Walk Distance [ Time Frame: 1 x at baseline ]
  19. Epworth Sleepiness Scale (ESS) [ Time Frame: 1 x at baseline ]
    Measure Description: ESS is a self-administered questionnaire. It contains 8 questions. Questions are rated on a 4-point Likert scale (0-3); 0= would never doze, 3=high Chance of dozing. Range of scores 0-24. Global score= sum of all item scores. Copyright (c)MW Johns

  20. Apnoea-Hypopnea-Index (AHI) at Baseline [ Time Frame: 1 x at baseline ]
    Measure Description: The AHI is an index to describe the severity of Sleep Apnea. Apnea is cessation of breathing during sleep. Hypopnea is diminished breathing during sleep. The number of Apneas and Hypopneas are added up and divided by hours of sleep (Apneas + Hypopneas per hour). An AHI ranging from 5-15 describes mild Sleep Apnea. AHI 15-30 describes moderate Sleep Apnea. AHI >30 describes severe Sleep Apnea.

  21. Central Apnoea Index/Total AHI [ Time Frame: 1 x at baseline ]
    Measure Description: Central apneas are partial or complete cessations of airflow caused by reduced or stopped neural Stimulation of the breathing muscles. For comparison: In obstructive apneas are caused by blocked airways that shut off the air although the breathing Stimulus is working.

  22. Central AHI/Total AHI at Baseline [ Time Frame: 1 x at baseline ]
  23. Oxygen Desaturation Index (ODI) at Baseline [ Time Frame: 1 x at baseline ]
    Number of oxygen desaturations per hour at baseline

  24. Oxygen Saturation Baseline [ Time Frame: 1 x at baseline ]
  25. Time With Oxygen Saturation Below 90% [ Time Frame: 1 x at baseline ]
  26. Time Until Unplanned Hospitalisation/Prolongation of Hospitalisation for Cardiovascular Cause or Cardiovascular Death/ Time Frame [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  27. Percent of Follow up Days Which Patient Survives and is Not Hospitalized/Hospital Stay is Not Prolonged for Cardiovascular Cause [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  28. Changes in NYHA Classification as Compared to Baseline [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  29. Changes in QoL (Minnesota) as Compared to Baseline [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  30. 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, assessed for up to 70 weeks ]
  31. Changes in Six Minute Walking Distance (6MWD) as Compared to Baseline [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  32. Changes of AHI and Oxygen Desaturation Index Compared to Baseline [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  33. AHI Below 10 Per Hour at Twelve Months and ODI Below 5 Per Hour at Twelve Months [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  34. Atrial Fibrillation at Follow-up Visits [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  35. 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: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  36. Difference in Utilities / QoL (Minnesota and EQ5D) Compared to Control Arm [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  37. Difference in Cost of Resources Consumed [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  38. Incremental Cost-efficacy Ratio [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]
  39. Incremental Cost-utility Ratio [ Time Frame: the last follow up or at the last available observation within FU, assessed for up to 70 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be at least 22 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 ≤45% 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 24 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 (angiotensin converting Enzyme) inhibitors/ ARB (angiotensin receptor blocker) 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
  • Patients for whom the use of AutoSet CS2 (TM)/VPAP Adapt may be contra-indicated because of symptomatic hypotension or significant intravascular volume depletion or pneumothorax or pneumomediastinum
  • Patient is able to fully understand study information and signed informed consent

Exclusion Criteria:

  • Significant COPD (chronic obstructive pulmonary disease) 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 (cardiac resynchronisation therapy)-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
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Information from the National Library of Medicine

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): NCT00733343


Locations
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Sponsors and Collaborators
ResMed
CRI-The Clinical Research Institute GmbH
Investigators
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Principal Investigator: Helmut Teschler, Prof. Universitätsklinikum Essen
Principal Investigator: Martin Cowie, Prof. National Heart and Lung Institute (NHLI) Brompton Hospital, London
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT00733343    
Other Study ID Numbers: 01
ISRCTN19572887 ( Other Identifier: International Standard Randomised Controlled Trials )
First Posted: August 13, 2008    Key Record Dates
Results First Posted: May 12, 2020
Last Update Posted: May 12, 2020
Last Verified: April 2020
Keywords provided by ResMed:
heart failure (HF)
sleep disordered breathing (SDB)
sleep apnea
left ventricular systolic dysfunction
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Respiratory Aspiration
Sleep Apnea, Central
Heart Failure
Heart Diseases
Cardiovascular Diseases
Apnea
 Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes