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Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment

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ClinicalTrials.gov Identifier: NCT02583906
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Prof Dr Catharina belge, Universitaire Ziekenhuizen Leuven

Brief Summary:
Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing.

Condition or disease Intervention/treatment Phase
Sleep-Disordered Breathing Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension Device: CPAP Not Applicable

Detailed Description:

The primary endpoint of the study is to evaluate the effect of CPAP therapy on pulmonary vascular resistance in PAH and CTEPH patients suffering from sleep disordered breathing.

The secondary endpoints are the effect of CPAP on right atrium and right ventricle diameter and ejection fraction measured by echocardiography, 6 minutes walk distance, NYHA class, QOL, endothelial function, sympathetic activity and prognosis.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
Study Start Date : April 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019


Arm Intervention/treatment
cpap treatment
patients randomized to the 'no cpap' arm will not be treated by CPAP
Device: CPAP
Treatment with CPAP for six months in the CPAP arm.
Other Name: CONTINUOUS POSITIVE AIRWAY PRESSURE

No Intervention: no cpap
patients randomized to the 'cpap' arm will be treated by CPAP



Primary Outcome Measures :
  1. Change in PVR (pulmonary vascular resistance) [ Time Frame: change in PVR from inclusion at 6 months ]


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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:

  • minimum 18 years old
  • diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension
  • diagnosis of PAH based on cardiac catherisation
  • diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy
  • recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before inclusion showing AHI above 15) stable clinical condition for at least 3 months before inclusion as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months

Exclusion Criteria:

  • congenital heart disease
  • moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1<60% of the predicted value
  • BMI 35kg/m2 or more
  • patients already treated with CPAP
  • patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)

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): NCT02583906


Contacts
Contact: Catharina Belge, MDPhD +3216346800

Locations
Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Catharina Belge    +3216346800      
Principal Investigator: Catharina Belge, MD PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Catharina Belge, MDPhD University Hospitals Leuven

Responsible Party: Prof Dr Catharina belge, Prof Dr Catharina Belge, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02583906     History of Changes
Other Study ID Numbers: S55742
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Respiratory Aspiration
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes