Status:
COMPLETED
Mechanisms of Action of Adaptive Servoventilation
Lead Sponsor:
ResMed
Collaborating Sponsors:
Royal Brompton & Harefield NHS Foundation Trust
Imperial College London
Conditions:
Heart Failure
Sleep Apnea Syndromes
Eligibility:
All Genders
18+ years
Brief Summary
It is known that a significant proportion of patients with heart failure have sleep disordered breathing (SDB). Some of these patients will have Central Sleep Apnoea which is one form of SDB. The SERV...
Detailed Description
As part of a wider study we are interested in how patients with a failing heart breathe during sleep. It is known that patients with heart failure and central sleep apnoea (a form of breathing difficu...
Eligibility Criteria
Inclusion
- Over 18 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 12 months
- Left ventricular ejection fraction (LVEF) \<40% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
- Diagnosis of sleep disordered breathing SDB (apnoea-hypopnoea-index (AHI \>15/h) with ≥ 50% central events and a central AHI ≥ 10/h)
- Clinically stable with no change in medication and no hospitalisation in preceding month
- Optimised medical treatment according to the applicable guidelines
- Able to provide informed consent
Exclusion
- Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1) \<50%
- 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 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00976417
Start Date
September 1 2009
End Date
October 1 2011
Last Update
December 7 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Brompton Hospital and Imperial College
London, United Kingdom