Trial document




drksid header

  DRKS00013883

Trial Description

start of 1:1-Block title

Title

The comparative pathophysiology of central sleep apnoea in patients with left sided heart failure, right sided heart failure and in patients with normal cardiac function but neurological background

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Central sleep apnoea (CSA) mainly occurs in patients with heart failure, renal failure and a history of stroke.
In left sided heart failure it has been reliably shown that the severity of CSA (especially its cycle lengths) is inversely correlated with left ventricular pump function. The pathomechanism behind this is a measurable increase in central respiratory drive in these patients. However, the pathophysiological pathway from systolic (left) ventricular dysfunction to this increased central respiratory drive remains incompletely understood.
What is even less clear is the pathophysiology of both CSA in patients with right sided heart failure due to Nizza class I pulmonary arterial Hypertension (PAH) and in patients with normal cardiac function. This study therefore aims to shed light to the pathophysiology of CSA in the before mentioned three Groups of patients making use of modern Imaging techniques and measurements of central respiratory drive. Furthermore the physiological effect of CSA on autonomic nervous System function and hemodynamics at night will be explored.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00013883
  •   2018/03/16
  •   [---]*
  •   yes
  •   Approved
  •   2017-188-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I50.1 -  Left ventricular failure
  •   I50.0 -  Congestive heart failure
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   In 10 patients with predominantly central sleep apnoea (CSA) due to right sided heart failure due to Nizza class I pulmonary arterial Hypertension (PAH) an attended overnight polysomnography will be carried out in our University sleep lab. During this night a non-invasive hemodynamic Monitor will continuously collect data on heart rate, blood pressure, their variability and bioimpedance based stroke volume. This data will be analysed whilst taking into account sleep stages and breathing patterns.
    Furthermore a cardiac MRI will be performed. At daytime hypercapnic ventilatory response (and hence central respiratory drive) as well as lung function testing incl. blood gas analysis and a 6 Minute Walk Test will be performed.
  •   10 patients with central sleep apnoea due to heart failure with reduced ejection fraction (HFrEF) will undergo the Study protocol described above.
  •   10 patients with idiopathic central sleep apnoea with normal cardiac function will undergo the Study protocol described above.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Mean heart rate [bpm], high frequency component of heart rate variability [%], low frequency component of diastolic blood pressure variability [%]

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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 [%], respiratory rate [/min], tidal volume [ml], minute ventilation [L/min], oxygen saturation [%], transcutaneous CO2 [mmHG], sleep stage Non-Rem I [%], sleep stage Non-Rem II [%], sleep stage Non-Rem III [%], sleep stage REM [%], Awake [%], Arousal Index [/h], rightventricular ejection fraction on MRI [%], leftventricular ejection fraction on MRI [%], hypercapnic ventilatory response testing (HCVR) [l/min/mmHG endexpiratory CO2], Apnoea-Hypopnoea-Index [/h], Hypopnoea-Index [/h], central Apnoea-Index [/h], obstructive Apnoea-Index [/h], cycle lengths of obstructive events [sec], cycle lengths of central events [sec], length of CSA-CSR [sec], modified Borg Dyspnoea Scale [Points; questionaire], Epworth Sleepiness Scale [points; questionaire], Berlin Sleep Apnoea Questionaire [points; questionaire], Pittsburgh Sleep Quality Index [points; questionaire], Minnesota Living with Heart Failure Questionaire [points; questionaire], modified Fatigue Severity Scale [points; questionaire], Medical Research Council Breathlessness Scale [points; questionaire], vital capacity [ml], FEV1/FVC [%], maximal inspiratory pressure [cmH2O], maximal exspiratory pressure [cmH2O], pO2 [mmHG], pCO2 [mmHG], 6 MWD (6 Minute Walk Distance) [m]

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/04/01
  •   30
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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. predominant central sleep apnoea as defined as AHI>15/h and >50% central events and a central AHI >10/h derived from full overnight attended polysomnography (Group 1, 2 and 3)
d. 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) (Group 1 and 2)
e. Controls (matched for age and gender) with idopathic central sleep apnoea with normal findings on echocardiogram, electrocardiogram and normal levels of natriuretic peptide hormone (Group 3)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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
- severe psychiatric pre-existing conditions

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Mr.  Dr. med.  Matthias  Boentert 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Klinik für angeborene (EMAH) und erworbene Herzfehler Universitätsklinikum Münster
    • Mr.  Prof. Dr. Dr.  Paul-Gerhard  Diller 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Medizinische Klinik A Universitätsklinikum Münster
    • Mr.  PD Dr. med.  Michael  Mohr 
    • Albert Schweitzer Campus 1
    • 48149  Münster
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Klinik für Kardiologie
    • Mr.  Univ.-Prof. Dr. med.  Ali  Yilmaz 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Clemens Hospital Münster
    • Mr.  Prof. Dr.  Olaf  Oldenburg 
    • Düesbergweg 124
    • 48153  Münster
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Mr.  Dr. med.  Jens  Spiesshoefer 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Schlafmedizin und neuromuskuläre Erkrankungen Universitätsklinikum Münster
    • Mr.  Dr. med.  Jens  Spiesshoefer 
    • Albert-Schweitzer-Campus 1
    • 48149  Münster
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Else Kröner-Fresenius-Stiftung (A109)
    • Am Pilgerrain 15
    • 61352  Bad Homburg v.d.H.
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2019/01/07
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.