Back to resultsPositive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure (ParadiseHF)
Primary Purpose
Diastolic Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Adaptive servo ventilation (ASV)
Sponsored by
About this trial
This is an interventional treatment trial for Diastolic Heart Failure focused on measuring diastolic heart failure
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
Sites / Locations
- University Hospital Regensburg
- Heart and Diabetes Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adaptive servo ventilation (ASV)
Arm Description
This group will receive ventilation therapy (AutoSet CS, ASV device)
Outcomes
Primary Outcome Measures
Change in Apnea-Hypopnea-Index (AHI)
Secondary Outcome Measures
Change in total sleeping time (TST) determined by parameters of polysomnography
Total sleeping time (TST) will be measured in minutes (min).
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).
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.
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.
Change of echocardiographic parameters of diastolic function
Change of NYHA stage
Change of nocturia
Changes of questionnaires: ESS
ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.
Changes of questionnaires: MLHFQ
MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient.
Changes of questionnaires (PHQ9)
PHQ9 (Patient health questionnaire) assesses depression of a patient.
Changes of questionnaires (SF12HSQ)
SF12HSQ (short form health status) assesses physical and mental health status.
Change in NT-pro BNP and BNP
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
Change of galactin-3
Change in 6 minute walk test (MWT)
Hospitalisations (reason)
Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?
Hospitalisations (cumulative length)
Length of hospitalizations are measured in days (d). Severity of disease.
Change in morning blood pressure
Change in morning heart rate
Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)
Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest
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)
Parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with arrhythmias.
Analysis of compliance data
Changes in spiroergometry data (substudy)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02254382
Brief Title
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
Acronym
ParadiseHF
Official Title
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment rates too low
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure
Keywords
diastolic heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptive servo ventilation (ASV)
Arm Type
Experimental
Arm Description
This group will receive ventilation therapy (AutoSet CS, ASV device)
Intervention Type
Device
Intervention Name(s)
Adaptive servo ventilation (ASV)
Other Intervention Name(s)
AutoSet CS
Intervention Description
Non-invasive Ventilation used to control central and obstructive sleep apnea.
Primary Outcome Measure Information:
Title
Change in Apnea-Hypopnea-Index (AHI)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in total sleeping time (TST) determined by parameters of polysomnography
Description
Total sleeping time (TST) will be measured in minutes (min).
Time Frame
6 months
Title
Change in sleep quality determined by parameters of polysomnography
Description
Sleep Quality will be defined by sleep architecture (time spent in sleep Phase 1,2,3 and REM).
Time Frame
6 months
Title
Change in sleep efficacy determined by parameters of polysomnography
Description
Sleep efficacy is defined as TST/total time spent in bed, i.e. sleep/awake periods.
Time Frame
6 months
Title
Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è
Description
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
Title
Change of echocardiographic parameters of diastolic function
Time Frame
6 months
Title
Change of NYHA stage
Time Frame
6 months
Title
Change of nocturia
Time Frame
6 months
Title
Changes of questionnaires: ESS
Description
ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.
Time Frame
6 months
Title
Changes of questionnaires: MLHFQ
Description
MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient.
Time Frame
6 months
Title
Changes of questionnaires (PHQ9)
Description
PHQ9 (Patient health questionnaire) assesses depression of a patient.
Time Frame
6 months
Title
Changes of questionnaires (SF12HSQ)
Description
SF12HSQ (short form health status) assesses physical and mental health status.
Time Frame
6 months
Title
Change in NT-pro BNP and BNP
Description
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.
Time Frame
6 months
Title
Changes in blood gas analysis
Time Frame
6 months
Title
Change of galactin-3
Time Frame
6 months
Title
Change in 6 minute walk test (MWT)
Time Frame
6 months
Title
Hospitalisations (reason)
Description
Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?
Time Frame
6 months
Title
Hospitalisations (cumulative length)
Description
Length of hospitalizations are measured in days (d). Severity of disease.
Time Frame
6 months
Title
Change in morning blood pressure
Time Frame
6 months
Title
Change in morning heart rate
Time Frame
6 months
Title
Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame
6 months
Title
Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest
Description
Electrocardiogram parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with normal heart function.
Time Frame
6 months
Title
Changes in occurrence of ventricular and supraventricular arrhythmias (PSG-ECG)
Description
Parameters are being put together to assess the patient's heart function status. Outcome: Number of patients with arrhythmias.
Time Frame
6 months
Title
Analysis of compliance data
Time Frame
6 months
Title
Changes in spiroergometry data (substudy)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaf Oldenburg, MD
Organizational Affiliation
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Regensburg
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
Heart and Diabetes Centre
City
Bad Oeynhausen
State/Province
North Rhine-Westphalia
ZIP/Postal Code
32545
Country
Germany
12. IPD Sharing Statement
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Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
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