NCT02583906

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2014

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 27, 2023

Status Verified

November 1, 2020

Enrollment Period

5.1 years

First QC Date

April 28, 2014

Last Update Submit

January 26, 2023

Conditions

Sleep-Disordered BreathingPulmonary Arterial HypertensionChronic Thromboembolic Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in PVR (pulmonary vascular resistance)

    change in PVR from inclusion at 6 months

Study Arms (2)

cpap treatment

OTHER

patients randomized to the 'no cpap' arm will not be treated by CPAP

Device: CPAP

no cpap

NO INTERVENTION

patients randomized to the 'cpap' arm will be treated by CPAP

Interventions

CPAPDEVICE

Treatment with CPAP for six months in the CPAP arm.

Also known as: CONTINUOUS POSITIVE AIRWAY PRESSURE
cpap treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesPulmonary Arterial Hypertension

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHypertension, PulmonaryLung Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Catharina Belge, MDPhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2014

First Posted

October 22, 2015

Study Start

April 1, 2014

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

January 27, 2023

Record last verified: 2020-11

Locations

BE(1)