Trial document




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  DRKS00000489

Trial Description

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Title

Positive Airway Pressure Therapy in Diastolic Heart Failure and Obstructive Sleep Apnea – PARADISE Trial
Pilot Study

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Trial Acronym

PARADISE Pilot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In patients with diastolic heart failure (heart failure with preserved ejection fraction, HFPEF) sleep disordered breathing is a highly prevalent comorbidity. This study aims to evaluate therapeutic effects of continuous positive airway pressure therapy (CPAP) on HFPEF.
This pilot trial intends to clarify the number of patients that need to be included into a randomized, controlled multicentre trial as well as the follow-up period.
An overall number of 40 patients will be enrolled.
On the first study night all patients will undergo sleep studies to confirm the moderate to severe obstructive sleep apnoea.

On the second day, cardiac standard diagnostics, including echocardiography, cardiopulmonary exercise testing, 6 minute walk test, measurement of NT-proBNP, capillary blood gas analysis and 2 questionnaires (MLWHF= Minnesota Living with Heart Failure and
ESS= Epworth Sleepiness Scale) will be performed. In addition a 30 minute therapy introduction period during wakefulness and continuous blood prerssure monitoring will be done.
On the second night, therapy introduction will be performed using full sleep studies.

Follow-up investigations are planned at 2-4weeks, 3, and 6 months, and include cardiac standard diagnostics as well as sleep studies (only at 3 and 6 months follow-up visits).

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Brief Summary in Scientific Language

In patients with diastolic heart failure (heart failure with preserved ejection fraction, HFPEF) sleep disordered breathing is a highly prevalent comorbidity. This study aims to evaluate therapeutic effects of continuous positive airway pressure therapy (CPAP) on HFPEF.
This pilot trial intends to clarify the effect-power for case calculation and the follow-up period for the planned randomized, controlled multicentre trial.
An overall number of 40 patients will be enrolled.
On the first study night all patients will undergo sleep studies to confirm the moderate to severe obstructive sleep apnoea.

On the second day, cardiac standard diagnostics, including echocardiography, cardiopulmonary exercise testing, 6 minute walk test, measurement of NT-proBNP, capillary blood gas analysis and 2 questionnaires (MLWHF= Minnesota Living with Heart Failure and
ESS= Epworth Sleepiness Scale) will be performed. In addition a 30 minute therapy introduction period during wakefulness and continuous blood prerssure monitoring will be done.

On the second night, therapy introduction will be performed, undergoing full sleep studies again.

Follow-up investigations are planned at 2-4 weeks, 3, and 6 months, and include cardiac standard diagnostics as well as sleep studies (only at 3 and 6 months follow-up visits).

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Organizational Data

  •   DRKS00000489
  •   2010/07/20
  •   [---]*
  •   yes
  •   Approved
  •   23/2010, Ethikkommission der Medizinischen Fakultät der Ruhr-Universität Bochum, Sitz Bad Oeynhausen
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Secondary IDs

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Health Condition or Problem studied

  •   I50.19 -  [generalization I50.1: Left ventricular failure]
  •   G47.31 -  [generalization G47.3: Sleep apnoea]
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Interventions/Observational Groups

  •   Automatic, continuous positive airway pressure (APAP/CPAP) for 6 months
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
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Primary Outcome

Improvement of diastolic function (e/E’) with TDI after 2-4 weeks, 3 months, and 6 months

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Secondary Outcome

at follow-up (2-4 weeks, 3 months, and 6months):
- Changes in functional NYHA-class
- Changes in NT-proBNP
- Changes in Cardiopulmonary exercise capacity (VO2 peak, predicted VO2 peak, VO2 AT)
- Changes in walk distance within 6 minutes
- Changes in left atrial diameter (LAD), Changes in intraventricular and posterior wall thickness
- Changes in Epworth Sleepiness Scale (ESS), and Minnesota Living With Heart Failure Score (MLWHF)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2010/08/02
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

- HFPEF, diagnosed according to current ESC guidelines
- Stable conditions for at least 6 weeks prior to inclusion period
- Pre-diagnosed moderate to severe Obstructive Sleep Apnoeas with an AHI of ≥ 15/h
- no electrical devices implantation within the last 6months
- pacing time < 10% of total

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Exclusion Criteria

- Myocardial infarction, cardiothoracic surgery, stroke, or onset of atrial fibrillation within the last 3 months
- changes in cardiovascular medication within the last6 weeks
- uncontrolled arterial hypertension (resting BP > 160/95mmHg on two consecutive days)
- pregnancy
- COPD (FEV1/VC < 70%)
- Resting pCO2 >45mmHg and/or pO2 < 65mmHg (arterial/capillary)
- Renal insufficiency (GFR < 45ml/h)
- Valvular heart disease > I.°
- HCM, HOCM
- untreated or theraqpy refractory restless legs syndrome
- ongoing ventilation therapy

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Addresses

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    • Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
    • Mr.  Dr.  Thomas  Bitter 
    • Georgstr. 11
    • 32545  Bad Oeynhausen
    • Germany
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    • Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
    • Ms.  Astrid  Kleemeyer 
    • Georgstr. 11
    • 32545  Bad Oeynhausen
    • Germany
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    • Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
    • Mr.  Dr.  Thomas  Bitter 
    • Georgstr. 11
    • 32545  Bad Oeynhausen
    • Germany
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Sources of Monetary or Material Support

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    • ResMed Ltd.
    • 1 Elizabeth Macarthur Drive
    • 2153   Bella Vista, NSW
    • Australia
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Status

  •   Recruiting withdrawn before recruiting started
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.