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

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

    • 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

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)
Non-invasive Ventilation used to control central and obstructive sleep apnea.
Other Names:
  • AutoSet CS

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
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

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

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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