Status:
COMPLETED
Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
Lead Sponsor:
ResMed
Conditions:
Heart Failure
Sleep Disorder
Eligibility:
All Genders
22+ years
Phase:
PHASE4
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 fu...
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)...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT01164592
Start Date
August 1 2012
End Date
June 1 2015
Last Update
August 7 2015
Active Locations (94)
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1
Westmead Hospital
Westmead, New South Wales, Australia, 2145
2
Rivercity Private Hospital
Auchenflower, Queensland, Australia, 4066
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
4
Melbourne Sleep Disorders Centre
East Melbourne, Victoria, Australia, 3002