- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02254382
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure (ParadiseHF)
April 13, 2017 updated by: ResMed
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bavaria
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Regensburg, Bavaria, Germany, 93053
- University Hospital Regensburg
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North Rhine-Westphalia
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Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
- Heart and Diabetes Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adaptive servo ventilation (ASV)
This group will receive ventilation therapy (AutoSet CS, ASV device)
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Non-invasive Ventilation used to control central and obstructive sleep apnea.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Apnea-Hypopnea-Index (AHI)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 months
|
Change in sleep quality determined by parameters of polysomnography
Time Frame: 6 months
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Sleep Quality will be defined by sleep architecture (time spent in sleep Phase 1,2,3 and REM).
|
6 months
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Change in sleep efficacy determined by parameters of polysomnography
Time Frame: 6 months
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Sleep efficacy is defined as TST/total time spent in bed, i.e. sleep/awake periods.
|
6 months
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Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è
Time Frame: 6 months
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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.
|
6 months
|
Change of echocardiographic parameters of diastolic function
Time Frame: 6 months
|
6 months
|
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Change of NYHA stage
Time Frame: 6 months
|
6 months
|
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Change of nocturia
Time Frame: 6 months
|
6 months
|
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Changes of questionnaires: ESS
Time Frame: 6 months
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ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.
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6 months
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Changes of questionnaires: MLHFQ
Time Frame: 6 months
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MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient.
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6 months
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Changes of questionnaires (PHQ9)
Time Frame: 6 months
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PHQ9 (Patient health questionnaire) assesses depression of a patient.
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6 months
|
Changes of questionnaires (SF12HSQ)
Time Frame: 6 months
|
SF12HSQ (short form health status) assesses physical and mental health status.
|
6 months
|
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.
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6 months
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Changes in blood gas analysis
Time Frame: 6 months
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6 months
|
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Change of galactin-3
Time Frame: 6 months
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6 months
|
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Change in 6 minute walk test (MWT)
Time Frame: 6 months
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6 months
|
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Hospitalisations (reason)
Time Frame: 6 months
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Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?
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6 months
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Hospitalisations (cumulative length)
Time Frame: 6 months
|
Length of hospitalizations are measured in days (d).
Severity of disease.
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6 months
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Change in morning blood pressure
Time Frame: 6 months
|
6 months
|
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Change in morning heart rate
Time Frame: 6 months
|
6 months
|
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Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame: 6 months
|
6 months
|
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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.
|
6 months
|
Changes in occurrence of ventricular and supraventricular arrhythmias (PSG-ECG)
Time Frame: 6 months
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Parameters are being put together to assess the patient's heart function status.
Outcome: Number of patients with arrhythmias.
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6 months
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Analysis of compliance data
Time Frame: 6 months
|
6 months
|
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Changes in spiroergometry data (substudy)
Time Frame: 6 months
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olaf Oldenburg, MD, Herz- und Diabeteszentrum NRW, Bad Oeynhausen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
September 29, 2014
First Submitted That Met QC Criteria
September 29, 2014
First Posted (Estimate)
October 1, 2014
Study Record Updates
Last Update Posted (Actual)
April 17, 2017
Last Update Submitted That Met QC Criteria
April 13, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MA130514
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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