Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure

Conditions
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Diastolic Heart Failure

Intervention / Treatment
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* Device: Adaptive servo ventilation (ASV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptive servo ventilation (ASV)<br>This group will receive ventilation therapy (AutoSet CS, ASV device) | Device: Adaptive servo ventilation (ASV)<br>* Non-invasive Ventilation used to control central and obstructive sleep apnea.<br>* Other names: AutoSet CS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Apnea-Hypopnea-Index (AHI) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total sleeping time (TST) determined by parameters of polysomnography | Total sleeping time (TST) will be measured in minutes (min). | 6 months | 
| Change in sleep quality determined by parameters of polysomnography | Sleep Quality will be defined by sleep architecture (time spent in sleep Phase 1,2,3 and REM). | 6 months | 
| Change in sleep efficacy determined by parameters of polysomnography | Sleep efficacy is defined as TST/total time spent in bed, i.e. sleep/awake periods. | 6 months | 
| Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è | 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. | 6 months | 
| Change of echocardiographic parameters of diastolic function |  | 6 months | 
| Change of NYHA stage |  | 6 months | 
| Change of nocturia |  | 6 months | 
| Changes of questionnaires: ESS | ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime. | 6 months | 
| Changes of questionnaires: MLHFQ | MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient. | 6 months | 
| Changes of questionnaires (PHQ9) | PHQ9 (Patient health questionnaire) assesses depression of a patient. | 6 months | 
| Changes of questionnaires (SF12HSQ) | SF12HSQ (short form health status) assesses physical and mental health status. | 6 months | 
| Change in NT-pro BNP and BNP | 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. | 6 months | 
| Changes in blood gas analysis |  | 6 months | 
| Change of galactin-3 |  | 6 months | 
| Change in 6 minute walk test (MWT) |  | 6 months | 
| Hospitalisations (reason) | Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated? | 6 months | 
| Hospitalisations (cumulative length) | Length of hospitalizations are measured in days (d). Severity of disease. | 6 months | 
| Change in morning blood pressure |  | 6 months | 
| Change in morning heart rate |  | 6 months | 
| Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE) |  | 6 months | 
| Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest | Electrocardiogram parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with normal heart function. | 6 months | 
| Changes in occurrence of ventricular and supraventricular arrhythmias (PSG-ECG) | Parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with arrhythmias. | 6 months | 
| Analysis of compliance data |  | 6 months | 
| Changes in spiroergometry data (substudy) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diastolic heart failure