I50.19 G47.31
Conditions
Interventions
Group 1: Automatic, continuous positive airway pressure (APAP/CPAP) for 6 months
Sponsors
Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: - HFPEF, diagnosed according to current ESC guidelines - Stable conditions for at least 6 weeks prior to inclusion period - Pre-diagnosed moderate to severe Obstructive Sleep Apnoeas with an AHI of = 15/h - no electrical devices implantation within the last 6months - pacing time < 10% of total
Exclusion criteria
Exclusion criteria: - Myocardial infarction, cardiothoracic surgery, stroke, or onset of atrial fibrillation within the last 3 months - changes in cardiovascular medication within the last6 weeks - uncontrolled arterial hypertension (resting BP > 160/95mmHg on two consecutive days) - pregnancy - COPD (FEV1/VC 45mmHg and/or pO2 I.° - HCM, HOCM - untreated or theraqpy refractory restless legs syndrome - ongoing ventilation therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of diastolic function (e/E’) with TDI after 2-4 weeks, 3 months, and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| at follow-up (2-4 weeks, 3 months, and 6months): - Changes in functional NYHA-class - Changes in NT-proBNP - Changes in Cardiopulmonary exercise capacity (VO2 peak, predicted VO2 peak, VO2 AT) - Changes in walk distance within 6 minutes - Changes in left atrial diameter (LAD), Changes in intraventricular and posterior wall thickness - Changes in Epworth Sleepiness Scale (ESS), and Minnesota Living With Heart Failure Score (MLWHF) | — |
Countries
Germany
Contacts
Public ContactThomas Bitter
Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
Outcome results
None listed