Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
- Conditions
- Diastolic Heart Failure
- Interventions
- Device: Adaptive servo ventilation (ASV)
- Registration Number
- NCT02254382
- Lead Sponsor
- ResMed
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adaptive servo ventilation (ASV) Adaptive servo ventilation (ASV) This group will receive ventilation therapy (AutoSet CS, ASV device)
- Primary Outcome Measures
Name Time Method Change in Apnea-Hypopnea-Index (AHI) 6 months
- Secondary Outcome Measures
Name Time Method Change of nocturia 6 months Changes of questionnaires: ESS 6 months ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.
Change of galactin-3 6 months Changes in spiroergometry data (substudy) 6 months Change in morning heart rate 6 months Change of echocardiographic parameters of diastolic function 6 months Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è 6 months E (mitral inflow velocity) and è (mitral annular early diastolic velocity) are parameters to measure filling of the left ventricle with blood.The E/è Ratio gives an estimation of the filling pressure of the left ventricle.
Change of NYHA stage 6 months Change in total sleeping time (TST) determined by parameters of polysomnography 6 months Total sleeping time (TST) will be measured in minutes (min).
Change in sleep quality determined by parameters of polysomnography 6 months Sleep Quality will be defined by sleep architecture (time spent in sleep Phase 1,2,3 and REM).
Change in sleep efficacy determined by parameters of polysomnography 6 months Sleep efficacy is defined as TST/total time spent in bed, i.e. sleep/awake periods.
Change in 6 minute walk test (MWT) 6 months Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest 6 months Electrocardiogram parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with normal heart function.
Analysis of compliance data 6 months Changes of questionnaires: MLHFQ 6 months MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient.
Changes of questionnaires (PHQ9) 6 months PHQ9 (Patient health questionnaire) assesses depression of a patient.
Changes of questionnaires (SF12HSQ) 6 months SF12HSQ (short form health status) assesses physical and mental health status.
Change in NT-pro BNP and BNP 6 months NT-pro BNP and BNP (unit ng/l) are comprehensive protein markers of heart diseases, inflammations and cardiovascular disorders. Outcome: Assessment of heart disease status.
Changes in blood gas analysis 6 months Hospitalisations (reason) 6 months Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?
Change in morning blood pressure 6 months Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE) 6 months Changes in occurrence of ventricular and supraventricular arrhythmias (PSG-ECG) 6 months Parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with arrhythmias.
Hospitalisations (cumulative length) 6 months Length of hospitalizations are measured in days (d). Severity of disease.
Trial Locations
- Locations (2)
Heart and Diabetes Centre
🇩🇪Bad Oeynhausen, North Rhine-Westphalia, Germany
University Hospital Regensburg
🇩🇪Regensburg, Bavaria, Germany