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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive servo ventilation (ASV) | Experimental | This group will receive ventilation therapy (AutoSet CS, ASV device) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive servo ventilation (ASV) | Device | Non-invasive Ventilation used to control central and obstructive sleep apnea. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Apnea-Hypopnea-Index (AHI) | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olaf Oldenburg, MD | Herz- und Diabeteszentrum NRW, Bad Oeynhausen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Regensburg | Regensburg | Bavaria | 93053 | Germany | ||
| Heart and Diabetes Centre |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| Bad Oeynhausen |
| North Rhine-Westphalia |
| 32545 |
| Germany |