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Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure (ParadiseHF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254382
Recruitment Status : Terminated (Recruitment rates too low)
First Posted : October 1, 2014
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
ResMed

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.

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Device: Adaptive servo ventilation (ASV) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
Study Start Date : March 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: AutoSet CS




Primary Outcome Measures :
  1. Change in Apnea-Hypopnea-Index (AHI) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. Change of echocardiographic parameters of diastolic function [ Time Frame: 6 months ]
  6. Change of NYHA stage [ Time Frame: 6 months ]
  7. Change of nocturia [ Time Frame: 6 months ]
  8. Changes of questionnaires: ESS [ Time Frame: 6 months ]
    ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.

  9. 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.

  10. Changes of questionnaires (PHQ9) [ Time Frame: 6 months ]
    PHQ9 (Patient health questionnaire) assesses depression of a patient.

  11. Changes of questionnaires (SF12HSQ) [ Time Frame: 6 months ]
    SF12HSQ (short form health status) assesses physical and mental health status.

  12. 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.

  13. Changes in blood gas analysis [ Time Frame: 6 months ]
  14. Change of galactin-3 [ Time Frame: 6 months ]
  15. Change in 6 minute walk test (MWT) [ Time Frame: 6 months ]
  16. Hospitalisations (reason) [ Time Frame: 6 months ]
    Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?

  17. Hospitalisations (cumulative length) [ Time Frame: 6 months ]
    Length of hospitalizations are measured in days (d). Severity of disease.

  18. Change in morning blood pressure [ Time Frame: 6 months ]
  19. Change in morning heart rate [ Time Frame: 6 months ]
  20. Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: 6 months ]
  21. 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.

  22. 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.

  23. Analysis of compliance data [ Time Frame: 6 months ]
  24. Changes in spiroergometry data (substudy) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254382


Locations
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Germany
University Hospital Regensburg
Regensburg, Bavaria, Germany, 93053
Heart and Diabetes Centre
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Olaf Oldenburg, MD Herz- und Diabeteszentrum NRW, Bad Oeynhausen
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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT02254382    
Other Study ID Numbers: MA130514
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Keywords provided by ResMed:
diastolic heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases