Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants
 with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV
 device; therapy group). The trial will run for 6 months, after which change in
 echocardiographic parameters of diastolic left ventricular function, sleep and quality of
 life parameters will be evaluated.
Inclusion Criteria:

 -  Clinical signs and symptoms of heart failure according to the ESC guidelines

 -  Echocardiographic evidence of a preserved systolic left ventricular function
 (echocardiographic left ventricular ejection fraction > 50%)

 -  Polysomnographic evidence of at least moderate sleep-disordered breathing:
 apnea-hypopnea index (AHI) > 15 / h with ≥ 50% central events and with with a central
 AHI of ≥ 10/h (AHI based on total sleeping time, TST)

 -  BNP or NT-pro BNP ≥ 300 pg / ml

 -  NYHA class II or III

 -  Patient tolerates the ventilation treatment (1h sample ventilation)

 -  Stable drug therapy in the last 4 weeks prior to randomization (no iv diuretic therapy
 or increasing the dose of diuretics to ≥ 100%)

 -  Minimum age of patients of 18 years

 -  patient willing to undergo study procedures

 -  signed informed consent

 Exclusion Criteria:

 -  Oxygen saturation (sO2) <92% of the days in peace without O2 therapy, measured
 baseline (start time) in the pulse oximetry or polysomnography in a cape. BGA (the
 measurement must be max. Lie back 1 week)

 -  Patients, who have a risk professional with symptomatic sleep apnea

 -  Known COPD with FEV1 <70%

 -  patients with NYHA stadium IV

 -  Advanced congenital heart defects

 -  pericardial diseases

 -  Existing PAP or bi-level therapy (including adaptive servo-ventilation) in the last 3
 months

 -  Acute cardiac event in the last 3 months

 -  BMI ≥ 35kg / m²

 -  Pregnant or lactating women