Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive Servo-ventilation in patients with Heart Failure

Completed

• Conditions: Heart failure with sleep disordered breathing; Circulatory System; Heart failure

• Registration Number: ISRCTN19572887
• Lead Sponsor: ResMed Ltd (Sydney, Australia)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23535165 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26323938 2016 secondary analysis in: http://www.ncbi.nlm.nih.gov/pubmed/27592224

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-15
• Study Completion: 2015-07-31
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1325

Inclusion Criteria

Current inclusion criteria as of 14/08/2012:
1. At least 18 years old
2. Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (European Society of Cardiology [ESC], American College of Cardiology [ACC]/American Heart Association [AHA])
3. Left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] less or equal than 45% by imaging method such as echocardiography, radionuclide (March, 6th 2009)
4. 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 (March, 6th 2009)
5. No hospitalisation for HF for at least 4 weeks prior to inclusion
6. 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 angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARB) antagonists the reasons must be documented
7. SDB (Apnoea-Hypopnoea Index [AHI] greater than 15/hour with greater than or equal to 50% central events and a central AHI greater than or equal to 10 hours, 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
8. Patient is able to fully understand study information and signed informed consent

Previous inclusion criteria until 14/08/2012:
1. At least 18 years old
2. Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (European Society of Cardiology [ESC], American College of Cardiology [ACC]/American Heart Association [AHA])
3. Left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] less than 40% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
4. New York Heart Association (NYHA) class III or IV at the time of inclusion or NYHA class II with at least one hospitalisation for heart failure (HF) in the last 12 months
5. No hospitalisation for HF for at least 4 weeks prior to inclusion
6. 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 angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARB) antagonists the reasons must be documented
7. SDB (Apnoea-Hypopnoea Index [AHI] greater than 15/hour with greater than or equal to 50% central events and a central AHI greater than or equal to 10 hours, 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
8. Patient is able to fully understand study information and signed informed consent

Exclusion Criteria

1. Significant chronic obstructive pulmonary disease (COPD) with forced expiratory volume within one second (FEV1) less than 50% (European Respiratory Society criteria) in the last four weeks before randomisation
2. Oxygen saturation at rest during the day less than or equal to 90% at inclusion
3. Current use of positive airway pressure (PAP) therapy
4. Life expectancy less than 1 year for diseases unrelated to chronic HF
5. Cardiac surgery, percutaneous coronary intervention (PCI), myocardial infarction (MI) or unstable angina within 6 months prior to randomisation
6. Cardiac resynchronisation therapy (CRT)-implantation or implanatable cardioverter-defibrillator (ICD)-implantation scheduled or within 6 months prior to randomisation
7. Transient ischaemic attack (TIA) or stroke within 3 months prior to randomisation
8. Primary haemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
9. Acute myocarditis/pericarditis within 6 months prior to randomisation
10. Untreated or therapy refractory restless legs-syndrome (RLS)
11. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified