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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01164592
First received: July 15, 2010
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Heart Failure
Sleep Disorder
Cheyne Stokes Respiration
Device: adaptive servoventilation (ASV)
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: SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in left and right ventricular function [ Time Frame: Baseline (Randomization), 6-and 12-month-Follow-up visit ] [ Designated as safety issue: Yes ]
  • Changes in LV systolic and diastolic indexed volumes [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ] [ Designated as safety issue: Yes ]
  • Changes in right ventricular (RV) systolic and diastolic indexed volumes [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ] [ Designated as safety issue: Yes ]
  • Changes in LV and RV mass [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ] [ Designated as safety issue: Yes ]
  • Changes in LV sphericity index and LV end-systolic global wall stress [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ] [ Designated as safety issue: Yes ]
  • Changes in sleep duration and sleep stages as well as arousals [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ] [ Designated as safety issue: Yes ]
  • Changes in sleep-disordered breathing [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ] [ Designated as safety issue: Yes ]
  • Changes in quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ] [ Designated as safety issue: Yes ]
  • Changes in mental status assessed by Mini-Mental State Examination (MMSE) [ Time Frame: Baseline (Randomization), 6- and 12-month-Follow-up-visit ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: August 2012
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: Therapy with adaptive servo ventilation
optimal medical therapy + adaptive servoventilation
Device: adaptive servoventilation (ASV)
Patients randomised to therapygroup should use the 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

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)
  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

INCLUSION CRITERIA FOR SERVE-HF STUDY:

  • 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

ADDITIONAL INCLUSION CRITERIA FOR THE SUBSTUDY

• 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

EXCLUSION CRITERIA FOR THE SERVE-HF STUDY:

  • 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

ADDITIONAL EXCLUSION CRITERIA FOR THE SUBSTUDY

  • Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
  • Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation
  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: NCT01164592

  Show 94 Study Locations
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Martin Cowie, Prof Royal Brompton Hospital, London
Study Director: Holger Woehrle, MD ResMed
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01164592     History of Changes
Other Study ID Numbers: 01a
Study First Received: July 15, 2010
Last Updated: May 28, 2013
Health Authority: Germany: Ethics Commission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: National Health Service
Australia: Human Research Ethics Committee
Netherlands: Independent Ethics Committee
Czech Republic: Ethics Committee
Finland: Ethics Committee
Switzerland: Comitato Etico Cantone Ticino

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

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

ClinicalTrials.gov processed this record on November 23, 2014