Sleep-disordered breathing in patients with implanted cardiac devices: assessment of the change in sensitivity to carbon dioxide with cardiac resynchronisation therapy
- Conditions
- Topic: Cardiovascular diseaseSubtopic: Cardiovascular (all Subtopics)Disease: CardiovascularCirculatory System
- Registration Number
- ISRCTN99704819
- Lead Sponsor
- Royal Brompton & Harefield NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Heart failure (of any aetiology) and a reduced ejection fraction (<40%) due to undergo implantation of a Boston Scientific biventricular pacemaker or defibrillator with the ApneaScan function
2. They must meet UK guidelines for biventricular pacemaker implantation
3. They should be on optimal medical therapy for heart failure
4. They must be aged 18 or over and be able to give valid written consent for this study
5. They must be ambulatory
Target Gender: Male & Female; Upper Age Limit 100 years ; Lower Age Limit 18 years
1. Patients receiving pacemakers without the ApneaScan function
2. Patients unable or unwilling to attend follow-up testing
3. Patients receiving devices for indications other than heart failure with reduced ejection fraction
4. Patients with obstructive sleep apnea already on continuous positive airway pressure (CPAP) therapy
5. Patients unable to walk
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hypercapnic Ventilatory Response; Timepoint(s): Change in Minute Ventilation per unit rise in end tidal CO2
- Secondary Outcome Measures
Name Time Method Apnoeic-Hypopnoeic Index; Timepoint(s): Measured at 6 weeks and 6 months post-implantation of pacemaker