Status:
TERMINATED
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
Lead Sponsor:
ResMed
Conditions:
Diastolic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 grou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02254382
Start Date
March 1 2016
End Date
March 1 2017
Last Update
April 17 2017
Active Locations (2)
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1
University Hospital Regensburg
Regensburg, Bavaria, Germany, 93053
2
Heart and Diabetes Centre
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545