Trial document





This trial has been registered retrospectively.
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  DRKS00006130

Trial Description

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Title

Acute hemodynamic effects of non-invasive ventilation in patients with Pulmonary hypertension

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

We want to study the hemodynamic effects of a non-invasive ventilation therapy in patients with percapillary pulmonary hypertension in comparison with patients with postcapillary pulmonary hypertension. These patients will undergo a right heart catheterization for diagnosis and classification regardless whether they participate in the study. After taking the baseline measurements, 15 minutes of ventilation therapy will be performed. Following this, a hemodynamic reevaluation will be done and compared to baseline results.

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Brief Summary in Scientific Language

Background: The haemodynamic effect of current non-invasive ventilation (NIV) therapy modes in pulmonary artery hypertension (PAH)has not yet been investigated. This study therefore aims to clarify the impact of NIV on pulmonary hemodynamics in PAH patients.
Methods: According to pre-specified sample-size analysis 18 patients with PAH (class I oder IV according to Nice-classification) versus 18 patients with postcapillary, pulmonary hypertension (class II) undergo right heart catheterization, followed by a 15 minutes period of NIV using Adaptive Servoventilation (ASV) and a 15 minutes observational period. At baseline, at the end of the ventilation period as well as at the end of the study hemodynamic measurement including pulmonary artery pressure, pulmonary capillary wedge pressure, right atrial pressure and cardiac index will be performed.

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Organizational Data

  •   DRKS00006130
  •   2014/06/03
  •   [---]*
  •   yes
  •   Approved
  •   1966-2013, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I27.0 -  Primary pulmonary hypertension
  •   I27.20 -  [generalization I27.2: Other secondary pulmonary hypertension]
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Interventions/Observational Groups

  •   Patients with pulmonary hypertension class I and IV according to Nice-Classification undergo a 15 minute period of Adaptive Servoventilation treatment during right-heart catheterization (indicated for clinical purposes). Hemodynamic measurement will be performed during ventilation therapy and compared with baseline results.
  •   Patients with pulmonary hypertension class II according to Nice-Classification undergo a 15 minute period of Adaptive Servoventilation treatment during right-heart catheterization (indicated for clinical purposes). Hemodynamic measurement will be performed during ventilation therapy and compared with baseline reults.
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Acute changes of pulmonary hemodynamics following a 15 minute period of non-invasive ventilation compared with data prior to therapy initiation and 15 minutes after therapy.

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Secondary Outcome

- changes in blood pressure during ventilation therapy
- subjective well-being during ventilation therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/31
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Evidence of pulmonary hypertension according to current guidelines of the European Society of cardiology (ESC)
therapy group: pulmonary hypertension class I and IV according to Nice-classification
control group: pulmonary hypertension class II according to Nice-classification,
informed consent

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Exclusion Criteria

pneumothorax,
severe pulmonary disease,
liquorhhea,
pregnancy,
intolerance of ventilation therapy during run-in phase

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Addresses

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr.  Karen  Olsson 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Medizinische Hochschule Hannover
    • Mr.  Dr.  Thomas  Bitter 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Mr.  Dr.  Thomas  Bitter 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover, Klinik für Pneumologie
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    •   0511/5320
    •   [---]*
    •   [---]*
    •   [---]*
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    • ResMed Germany Inc.
    • Fraunhoferstraße 16
    • 82152  Martinsried
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/25
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* This entry means the parameter is not applicable or has not been set.