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NCT02583906 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02583906
Other study ID # S55742
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 2014
Est. completion date May 2019

Study information
Verified date November 2020
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date May 2019
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• CPAP
Treatment with CPAP for six months in the CPAP arm.

Locations
Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in PVR (pulmonary vascular resistance) change in PVR from inclusion at 6 months
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