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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000446

Enrollment

Registered

2010-06-29

Start date

2009-02-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50.19 G47.3

Interventions

Group 1: Nocturnal, continuous automatic positive airway pressure (APAP) Group 2: breathing strip

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

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

Exclusion criteria: - implantation of a CRT-D device or upgrading within the last 12 weeks - significant COPD (FEV1/VC 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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Contacts

Public ContactAstrid Kleemeyer

Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum

akleemeyer@hdz-nrw.de05731 971258

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026