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

ResMed2 sites in 1 country2 target enrollmentMarch 2016

ConditionsDiastolic Heart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diastolic Heart Failure
Sponsor: ResMed
Enrollment: 2
Locations: 2
Primary Endpoint: Change in Apnea-Hypopnea-Index (AHI)
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

March 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ResMed

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Apnea-Hypopnea-Index (AHI)

Time Frame: 6 months

Secondary Outcomes

Change of nocturia(6 months)
Change of galactin-3(6 months)
Changes in spiroergometry data (substudy)(6 months)
Change of echocardiographic parameters of diastolic function(6 months)
Changes of questionnaires: ESS(6 months)
Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è(6 months)
Change of NYHA stage(6 months)
Change in total sleeping time (TST) determined by parameters of polysomnography(6 months)
Change in sleep quality determined by parameters of polysomnography(6 months)
Change in sleep efficacy determined by parameters of polysomnography(6 months)
Change in 6 minute walk test (MWT)(6 months)
Change in morning heart rate(6 months)
Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest(6 months)
Analysis of compliance data(6 months)
Changes of questionnaires: MLHFQ(6 months)
Changes of questionnaires (PHQ9)(6 months)
Changes of questionnaires (SF12HSQ)(6 months)
Change in NT-pro BNP and BNP(6 months)
Changes in blood gas analysis(6 months)
Hospitalisations (reason)(6 months)
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)
Hospitalisations (cumulative length)(6 months)