Clinical Trial: Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Positive Airway Pressure Therapy Study in Sleep Apnea and 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.
Detailed Summary:
Sponsor: ResMed
Current Primary Outcome: Change in Apnea-Hypopnea-Index (AHI) [ Time Frame: 6 months ]
Original Primary Outcome: Change in echocardiographic parameters of diastolic left ventricular function [ Time Frame: 6 months ]
Current Secondary Outcome:
- Change in total sleeping time (TST) determined by parameters of polysomnography [ Time Frame: 6 months ]Total sleeping time (TST) will be measured in minutes (min).
- Change in sleep quality determined by parameters of polysomnography [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
- Change of NYHA stage [ Time Frame: 6 months ]
- Change of nocturia [ Time Frame: 6 months ]
- Changes of questionnaires: ESS [ Time Frame: 6 months ]ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.
- Changes of questionnaires: MLHFQ [ Time Frame: 6 months ]MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient.
- Changes of questionnaires (PHQ9) [ Time Frame: 6 months ]PHQ9 (Patient health questionnaire) assesses depression of a patient.
- Changes of questionnaires (SF12HSQ) [ Time Frame: 6 months ]SF12HSQ (short form health status) assesses physical and mental health status.
- Change in NT-pro BNP and BNP [ Time Frame: 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.
- Changes in blood gas analysis [ Time Frame: 6 months ]
- Change of galactin-3 [ Time Frame: 6 months ]
- Change in 6 minute walk test (MWT) [ Time Frame: 6 months ]
- Hospitalisations (reason) [ Time Frame: 6 months ]Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?
- Hospitalisations (cumulative length) [ Time Frame: 6 months ]Length of hospitalizations are measured in days (d). Severity of disease.
- Change in morning blood pressure [ Time Frame: 6 months ]
- Change in morning heart rate [ Time Frame: 6 months ]
- Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: 6 months ]
- Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 6 months ]
- Changes in spiroergometry data (substudy) [ Time Frame: 6 months ]
Original Secondary Outcome:
Information By: ResMed
Dates:
Date Received: September 29, 2014
Date Started: March 2016
Date Completion:
Last Updated: April 13, 2017
Last Verified: April 2017