Clinical trial NCT02254382: Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
Official title: Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diastolic Heart Failure
Keywords: diastolic heart failure
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Apnea-Hypopnea-Index (AHI)
timeFrame: 6 months
Secondary outcomes:
measure: Change in total sleeping time (TST) determined by parameters of polysomnography
timeFrame: 6 months
measure: Change in sleep quality determined by parameters of polysomnography
timeFrame: 6 months
measure: Change in sleep efficacy determined by parameters of polysomnography
timeFrame: 6 months
measure: Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è
timeFrame: 6 months
measure: Change of echocardiographic parameters of diastolic function
timeFrame: 6 months
measure: Change of NYHA stage
timeFrame: 6 months
measure: Change of nocturia
timeFrame: 6 months
measure: Changes of questionnaires: ESS
timeFrame: 6 months
measure: Changes of questionnaires: MLHFQ
timeFrame: 6 months
measure: Changes of questionnaires (PHQ9)
timeFrame: 6 months
measure: Changes of questionnaires (SF12HSQ)
timeFrame: 6 months
measure: Change in NT-pro BNP and BNP
timeFrame: 6 months
measure: Changes in blood gas analysis
timeFrame: 6 months
measure: Change of galactin-3
timeFrame: 6 months
measure: Change in 6 minute walk test (MWT)
timeFrame: 6 months
measure: Hospitalisations (reason)
timeFrame: 6 months
measure: Hospitalisations (cumulative length)
timeFrame: 6 months
measure: Change in morning blood pressure
timeFrame: 6 months
measure: Change in morning heart rate
timeFrame: 6 months
measure: Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: 6 months
measure: Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest
timeFrame: 6 months
measure: Changes in occurrence of ventricular and supraventricular arrhythmias (PSG-ECG)
timeFrame: 6 months
measure: Analysis of compliance data
timeFrame: 6 months
measure: Changes in spiroergometry data (substudy)
timeFrame: 6 months
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Regensburg
state: Bavaria
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Centre
state: North Rhine-Westphalia
Study officials:
affiliation: Herz- und Diabeteszentrum NRW, Bad Oeynhausen
name: Olaf Oldenburg, MD
role: PRINCIPAL_INVESTIGATOR
References: