Trial document




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  DRKS00013659

Trial Description

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Title

Impact of different breathing patterns on autonomic nervous system function in patients with right-ventricular or left-ventricular dysfunction or with normal cardiac function

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Cheyne-Stokes Respiration (CSA-CSR) is characterized by an increased central respiratory drive that leads to periods of hyperventilation that alternate with central apneas.
Despite years of research in respiratory physiology there is still no clear consensus about the role of CSA-CSR in heart failure (HF). Likewise it remains unclear if and how this breathing pattern that is highly pravelent in HF should be treated.
Results of recent large scale randomized controlled trials that failed to show survival benefits in HF patients who received nocturnal (mask based) treatment of CSA-CSR (SERVE-HF Study) have revitalised the hypothesis that CSA-CSR is a compensatory mechanism of the failing heart and exerts favorable effects on autonomic nervous system function. However, the exact physiology behind this hypothesis remains unfully understood.
Therefore this study´s main aim is to shed light on answers to the following questions:
Does a simulation of two different CSA-CSR breathing patterns lead to (desired) favorable effects on surrogate markers of autonomic nervous system function and or/hemodynamics ?
What effects does an increase or a decrease in respiratory rate have on surrogate markers of autonomic nervous system function and or/hemodynamics ?
What effects does (voluntary) hyperventilation have on autonomic nervous system function and or/hemodynamics ?
In accordance with a sample size calculation conducted by the Institute of Medical Biometrics of Münster University Hospital (expert opinion obtained on July, 13th 2017) this will be done in a total of 60 patients with well-characterized left ventricular or rightventricular dysfunction or with normal cardiac function.

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Organizational Data

  •   DRKS00013659
  •   2018/03/15
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  •   yes
  •   Approved
  •   2017-186-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   I50.1 -  Left ventricular failure
  •   I50.0 -  Congestive heart failure
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Interventions/Observational Groups

  •   In 20 well-characterised patients with Nizza class I pulmonary arterial hypertension (PAH) continuous measurement of muscular sympathetic nerve activity (MSNA) and non invasive hemodynamic monitoring (blood pressure, heart rate, their variabilities and bioimpedance based stroke volume) will be performed over a total of about 2 hours [in our University sleep lab and at daytime].
    Patients will pass the following 3 experiments:
    I Simulation of CSA-CSR with different cycle lengths
    II Simulation of an incresed or a decreased respiratory rate
    III voluntary Hyperventilation
    The sequence of the experiments and the different breathing manoeuvres therein will be randomised and every manoeuver / experiment will be separated from one another by 15 minutes of normal breathing.
  •   20 patients with heart failure with reduced ejection fraction (HFrEF). Study protocol see above.
  •   20 control subjects. Study protocol see above.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Muscular sympathetic nerve activity [Burst rate/min; Burst rate/100 beats; measured through a microneurography device produced by AD Instruments with a small needle inserted in the peroneal nerve], high frequency component of heart rate variability [%; measured through a non-invasive hemodynamic Monitor -Task Force Monitor- produced by CNSystems], low frequency component of diastolic blood pressure variability [%; measured through a non-invasive hemodynamic Monitor -Task Force Monitor- produced by CNSystems]

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Secondary Outcome

Heart rate [bpm], systolic blood pressure [mmHG], diastolic blood pressure [mmHG], stroke volume index [L/min/m²], high frequency component of diastolic blood pressure variability[%], low frequency component of heart rate variability [%],
-> the above mentioned will be measured through a non-invasive hemodynamic Monitor -Task Force Monitor- produced by CNSystems
respiratory rate [/min], tidal volume [ml], minute ventilation [L/min], oxygen saturation [%], transcutaneous CO2 [mmHG]
-> the above mentioned will be measured through a polysomnography device produced by Nihon Kohden

->mean values under the different interventions will be obtained and compared

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/04/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

a. Age > 18 years (no age limit) (Group 1, 2 and 3)
b. able to consent (Group 1, 2 and 3)
c. Diagnosis of Nizza class I pumonary arterial Hypertension -PAH- and heart failure with reduced ejection fraction -HFrEF- according to the most recent Guidelines of the European Society of Cardiology (ESC); >12 weeks since the diagnosis of HFrEF / PAH has been made; no hospitalisation for HF in the last 4 weeks; optimal medical therapy in accordance with the most recent Guidelines of the European Society of Cardiology (ESC) with no change in medication in the last 4 weeks and combination therapy for both PAH and HFrEF -where there was no treatment with combination therapy in PAH patients or with beta blockers or ACE Inhibitors/ARBs in HFrEF, then the reason must be documented)
d. healthy controls (matched for age and gender) with normal findings on echocardiogram, electrocardiogram and normal levels of natriuretic peptide hormone (Group 3)

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Exclusion Criteria

- other severe internistic pre-existing conditions, especially insulin-dependent diabetes or severe renal impairment
- severe neurological pre-existing conditions such as stroke, especially brainstem infarction
- intake of opioids
- psychiatric pre-existing conditions

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Addresses

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    • Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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    • Klinik für angeborene (EMAH) und erworbene Herzfehler Universitätsklinikum Münster
    • Mr.  Prof. Dr. Dr.  Paul-Gerhard  Diller 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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    • Medizinische Klinik Albert-Schweitzer-Campus 1
    • Mr.  PD Dr. med.  Michael  Mohr 
    • Albert Schweitzer Campus 1
    • 48149  Münster
    • Germany
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    • Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Mr.  Dr. med.  Matthias  Boentert 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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    • Klinik für Kardiologie
    • Mr.  Univ.-Prof. Dr. med.  Ali  Yilmaz 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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    • Cardiovascular Medicine DivisionFondazione Toscana Gabriele Monasterio
    • Mr.  Dr.  Alberto  Giannoni 
    • via Giuseppe Moruzzi 1
    • 56124  Pisa
    • Italy
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    • Department of Clinical and Experimental MedicineUniversity of Pisa
    • Ms.  Prof. Dr.  Rosa Maria  Bruno 
    • Ospedale Santa Chiara, Building #8 Via Roma 67
    • 56124  Pisa
    • Italy
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    • Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Mr.  Dr. med.  Jens  Spiesshoefer 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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    • Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Mr.  Dr. med.  Jens  Spiesshoefer 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Else Kröner-Fresenius-Stiftung (A 109)
    • Am Pilgerrain 15
    • 61352  Bad Homburg v.d.H.
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/09/01
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Trial Publications, Results and other Documents

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