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

ResMed2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diastolic Heart Failure

Interventions

Adaptive servo ventilation (ASV)DEVICE

Non-invasive Ventilation used to control central and obstructive sleep apnea.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital Regensburg

Regensburg, Bavaria, Germany

Heart and Diabetes Centre

Bad Oeynhausen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Change in Apnea-Hypopnea-Index (AHI)

Time frame: 6 months

Secondary Outcomes

Change in total sleeping time (TST) determined by parameters of polysomnography

Total sleeping time (TST) will be measured in minutes (min).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Change of echocardiographic parameters of diastolic function

Time frame: 6 months

Change of NYHA stage

Time frame: 6 months

Change of nocturia

Time frame: 6 months

Changes of questionnaires: ESS

ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.

Data from ClinicalTrials.gov

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