Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation (MS)

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. Identifier: NCT01164592
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : August 7, 2015
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

Condition or disease Intervention/treatment Phase
Heart Failure Sleep Disorder Cheyne Stokes Respiration Device: adaptive servoventilation (ASV) Phase 4

Detailed Description:

This substudy is performed within the SERVE-HF Study, a randomised, multi-centre,international trial with parallel group design, with patients randomised to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. The randomization will be the same as in the parent study. For this purpose, the randomization of the parent study will be stratified as to whether a patient is included in the substudy or not. 300 patients will be recruited for the substudy overall.

For the purpose of this substudy, patients will be followed up for a period of 12 months.

The following extra tests will be performed at the baseline visit, the 3 months follow up and the 12 months follow up:

  • Echocardiogram (for both groups)
  • cMRI (for both groups)
  • PSG (at the baseline visit only for patients in the treatment group and at 3 months follow up and the 12 months follow up for all patients)
  • 4 questionnaires (for both groups)
  • Additional blood testing (for both groups)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
Study Start Date : August 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: Therapy with adaptive servo ventilation
optimal medical therapy + adaptive servoventilation
Device: adaptive servoventilation (ASV)
Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours
Other Name: Adaptive Servo-Ventilation with AutoSet CS

No Intervention: Optimal medical therapy according to guidelines
optimal medical therapy

Primary Outcome Measures :
  1. Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 12 months of therapy as measured by echocardiography (Echo). [ Time Frame: Baseline (Randomization), 6- and 12 month-Follow-up-visit ]

Secondary Outcome Measures :
  1. Changes in left and right ventricular function [ Time Frame: Baseline (Randomization), 6-and 12-month-Follow-up visit ]
  2. Changes in LV systolic and diastolic indexed volumes [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ]
  3. Changes in right ventricular (RV) systolic and diastolic indexed volumes [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ]
  4. Changes in LV and RV mass [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ]
  5. Changes in LV sphericity index and LV end-systolic global wall stress [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ]
  6. Changes in sleep duration and sleep stages as well as arousals [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ]
  7. Changes in sleep-disordered breathing [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ]
  8. Changes in quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ]
  9. Changes in mental status assessed by Mini-Mental State Examination (MMSE) [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ]
  10. Changes in Patient Health Questionnaire-9 (PHQ-9) score and Patient Anxiety Questionnaire GAD-7 [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ]

Information from the National Library of Medicine

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

The inclusion and exclusion criteria are mainly those applicable for the parent study; SERVE−HF. The inclusion and exclusion criteria are listed here.


  • Over 22 years of age
  • Severe Chronic Heart Failure (CHF) with NYHA class III−IV or NYHA class II with at least one hospitalisation for HF within the last 24 months
  • Left ventricular ejection fraction (LVEF) less than or equal to 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
  • Diagnosis of sleep disordered breathing (SDB) with an apnoea−hypopnoea−index (AHI) of >15/hr with at least 50% central events and a central AHI of at least 10/hr
  • Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month
  • Optimised medical treatment according to the applicable guidelines
  • Able to provide informed consent


• Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with ≥ 50% central events and a central AHI ≥10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements have to be performed with nasal cannula


  • Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted
  • Oxygen saturation at rest during the day 90% at the time of inclusion
  • Current use of Positive Airway Pressure (PAP) therapy
  • Life expectancy < 1 year for diseases unrelated to chronic heart failure
  • Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
  • Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) 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)
  • Pregnancy


  • Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
  • Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation

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 identifier (NCT number): NCT01164592

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Sponsors and Collaborators
Principal Investigator: Martin Cowie, Prof Royal Brompton Hospital, London
Study Director: Holger Woehrle, MD ResMed

Responsible Party: ResMed Identifier: NCT01164592     History of Changes
Other Study ID Numbers: 01a
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by ResMed:
Heart failure (HF)
Sleep disordered breathing (SDB)
Cheyne Stokes Respiration (CSR)
Adaptive Servoventilation (ASV)

Additional relevant MeSH terms:
Heart Failure
Sleep Wake Disorders
Cheyne-Stokes Respiration
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory