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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT00733343
First received: February 14, 2008
Last updated: May 28, 2013
Last verified: May 2013
  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 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 Intervention Phase
Heart Failure
Sleep Disordered Breathing
Device: Europe: AutoSet CS 2 (USA: VPAP Adapt SV)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ]
  • AHI and oxygen desaturation index [ Time Frame: Compared to baseline ] [ Designated as safety issue: No ]
    Changes of AHI and oxygen desaturation index compared to baseline

  • Changes in AHI and ODI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    AHI below 10 per hour at twelve months and ODI below 5 per hour at twelve months

  • Atrial Fibrillation [ Time Frame: n.a. ] [ Designated as safety issue: No ]
    Atrial fibrillation at follow-up visits


Estimated Enrollment: 1313
Study Start Date: February 2008
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Group
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
No Intervention: Control Group
standard medical therapy according to applicable guidelines (ESC, ACC/AHA)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
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 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
  • Patients for whom the use of AutoSet CS2/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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 267 Study Locations
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Helmut Teschler, Prof. Universitätsklinikum Essen
Principal Investigator: Martin Cowie, Prof. National Heart and Lung Institute (NHLI) Brompton Hospital, London
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT00733343     History of Changes
Other Study ID Numbers: 01, ISRCTN19572887
Study First Received: February 14, 2008
Last Updated: May 28, 2013
Health Authority: Denmark: Ethics Committee
Germany: Ethics Commission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: National Health Service
Norway:National Committee for Medical and Health Research Ethics
Sweden: Regional Ethical Review Board
Australia: Human Research Ethics Committee
Netherlands: Independent Ethics Committee
Czech Republic: Ethics Committee
Finland: Ethics Committee
Switzerland: Comitato Etico Cantone Tizino

Keywords provided by ResMed:
heart failure
sleep disordered breathing
sleep apnea
left ventricular systolic dysfunction
SBAS
HF

Additional relevant MeSH terms:
Apnea
Respiratory Aspiration
Heart Failure
Sleep Apnea Syndromes
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014