Effect of an automatic continuous positive airway pressure (APAP) ventilation therapy on exercise capacity in patients with congestive heart failure and obstructive sleep apnoea

• Conditions: I50.19; G47.3; Sleep apnoea

• Registration Number: DRKS00000446
• Lead Sponsor: Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-29
• Study Completion: 2016-11-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Diagnosis of congestive heart failure (CHF) obtained at least 12 weeks prior to inclusion
- LVEF = 45%
- optimal CHF treatment according to recent guidelines provided by the German Cardiac Society (DGK)
- Obstructive sleep apnoea (AHI >= 15/h) with = 25% central events
- routinely planned hospital admission for follow-up visits (3 and 6 months)
- stable medical heart failure therapy for at least 4 weeks prior to inclusion
- willingness to participate in this study
- written informed consent

Exclusion Criteria

- implantation of a CRT-D device or upgrading within the last 12 weeks
- significant COPD (FEV1/VC <70%)
- respiratory insufficieny requiring long-term oxygen therapy
- daytime hypercapnia (pCO2 >45mmHg)
- ongoing APAP, BiPAP or ASV therapy
- cardiothoracic surgery, PCI, myocardial infarction, transitory ischaemic attac or stroke within the last 12 weeks
- untreated or therapy refractory restless-legs syndrome
- acute myocarditis within the last 3 months
- pregnancy or breastfeeding women
- complex sleep apnoea during APAP-therapy initiation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in maximum oxygen uptake (VO2 peak) and oxygen uptake at the aerobic-anaerob threshold (VO2 AT) during cardiopulmonary exercise testing after 6 months

Secondary Outcome Measures

Name	Time	Method
Changes in<br>- apnoea-hypopnoea index (AHI)<br>- levft ventricular ejection fraction (LVEF)<br>- left ventricular diameters (LVEDD, LVESD)<br>- walk distance within 6 minutes<br>- serum levels of NT-proBNP<br>- Minnesota Living with Heart Failure score<br>- Epworth sleepiness scale score<br>- Blood gas sample analysis<br>- NYHA-class