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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • University Hospital Regensburg
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
        • Heart and Diabetes Centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adaptive servo ventilation (ASV)
This group will receive ventilation therapy (AutoSet CS, ASV device)
Device: Adaptive servo ventilation (ASV)
Non-invasive Ventilation used to control central and obstructive sleep apnea.
Other Names:
  • AutoSet CS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Apnea-Hypopnea-Index (AHI)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Sleep Quality will be defined by sleep architecture (time spent in sleep Phase 1,2,3 and REM).
6 months
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.
6 months
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.
6 months
Change of echocardiographic parameters of diastolic function
Time Frame: 6 months
6 months
Change of NYHA stage
Time Frame: 6 months
6 months
Change of nocturia
Time Frame: 6 months
6 months
Changes of questionnaires: ESS
Time Frame: 6 months
ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.
6 months
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.
6 months
Changes of questionnaires (PHQ9)
Time Frame: 6 months
PHQ9 (Patient health questionnaire) assesses depression of a patient.
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.
6 months
Changes in blood gas analysis
Time Frame: 6 months
6 months
Change of galactin-3
Time Frame: 6 months
6 months
Change in 6 minute walk test (MWT)
Time Frame: 6 months
6 months
Hospitalisations (reason)
Time Frame: 6 months
Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?
6 months
Hospitalisations (cumulative length)
Time Frame: 6 months
Length of hospitalizations are measured in days (d). Severity of disease.
6 months
Change in morning blood pressure
Time Frame: 6 months
6 months
Change in morning heart rate
Time Frame: 6 months
6 months
Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame: 6 months
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.
6 months
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.
6 months
Analysis of compliance data
Time Frame: 6 months
6 months
Changes in spiroergometry data (substudy)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ResMed

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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