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

January 26, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • CONTINUOUS POSITIVE AIRWAY PRESSURE
No Intervention: no cpap
patients randomized to the 'cpap' arm will be treated by CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in PVR (pulmonary vascular resistance)
Time Frame: change in PVR from inclusion at 6 months
change in PVR from inclusion at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Catharina Belge, MDPhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S55742

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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