Diastolic Heart Failure
Conditions
Keywords
diastolic heart failure
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.
Interventions
DEVICEAdaptive servo ventilation (ASV)
Non-invasive Ventilation used to control central and obstructive sleep apnea.
Sponsors
ResMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Apnea-Hypopnea-Index (AHI) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 echocardiographic parameters of diastolic function | 6 months | — |
| Change of NYHA stage | 6 months | — |
| Change of nocturia | 6 months | — |
| Changes of questionnaires: ESS | 6 months | ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime. |
| 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. |
| Change in total sleeping time (TST) determined by parameters of polysomnography | 6 months | Total sleeping time (TST) will be measured in minutes (min). |
| Change of galactin-3 | 6 months | — |
| Change in 6 minute walk test (MWT) | 6 months | — |
| Hospitalisations (reason) | 6 months | Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated? |
| Hospitalisations (cumulative length) | 6 months | Length of hospitalizations are measured in days (d). Severity of disease. |
| 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 | 6 months | Electrocardiogram parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with normal heart function. |
| 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. |
| Analysis of compliance data | 6 months | — |
| Changes in spiroergometry data (substudy) | 6 months | — |
| Changes in blood gas analysis | 6 months | — |
Countries
Germany
Outcome results
None listed