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

NCT ID: NCT02583906

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep-Disordered Breathing Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cpap treatment

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

Group Type OTHER

CPAP

Intervention Type DEVICE

Treatment with CPAP for six months in the CPAP arm.

no cpap

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPAP

Treatment with CPAP for six months in the CPAP arm.

Intervention Type DEVICE

Other Intervention Names

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CONTINUOUS POSITIVE AIRWAY PRESSURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catharina Belge, MDPhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S55742

Identifier Type: -

Identifier Source: org_study_id

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