Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Diagnostic Test: body plethysmography; Diagnostic Test: impulse oscillometry; Diagnostic Test: multiple breath washout

• Registration Number: NCT03667794
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

Little is known about affection of small airways in patients with pulmonary hypertension as well as the ideal diagnostic approach. The investigators therefore aimed to evaluate novel or not widely used lung function tests for the evaluation of airway function in patients with PH.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-01
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2018-09
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• known or first diagnosis of PH

Exclusion Criteria

• inability to perform lung function testing
• unable or unwilling to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PH patients	body plethysmography	Patients with known or first diagnosis of PH
healthy controls	body plethysmography	Healthy controls had normal lung function testing including whole-body plethysmography and transfer factor, no previously diagnosed pulmonary disease as well as no respiratory symptoms.
healthy controls	multiple breath washout	Healthy controls had normal lung function testing including whole-body plethysmography and transfer factor, no previously diagnosed pulmonary disease as well as no respiratory symptoms.
non-healthy controls	multiple breath washout	Non-healthy controls were allowed to have stable pulmonary comorbidities including chronic obstructive pulmonary disease (COPD), sarcoidosis, asthma, or fibrosis as well as non-pulmonary comorbidities.
PH patients	impulse oscillometry	Patients with known or first diagnosis of PH
PH patients	multiple breath washout	Patients with known or first diagnosis of PH
non-healthy controls	body plethysmography	Non-healthy controls were allowed to have stable pulmonary comorbidities including chronic obstructive pulmonary disease (COPD), sarcoidosis, asthma, or fibrosis as well as non-pulmonary comorbidities.
healthy controls	impulse oscillometry	Healthy controls had normal lung function testing including whole-body plethysmography and transfer factor, no previously diagnosed pulmonary disease as well as no respiratory symptoms.
non-healthy controls	impulse oscillometry	Non-healthy controls were allowed to have stable pulmonary comorbidities including chronic obstructive pulmonary disease (COPD), sarcoidosis, asthma, or fibrosis as well as non-pulmonary comorbidities.

Primary Outcome Measures

Name	Time	Method
LCI	30 minutes	between-group difference in lung clearance index (LCI)
D5-20	30 minutes	between-group difference in frequency dependence of resistance (D5-20)

Secondary Outcome Measures

Name	Time	Method
Discrimination small airway resistance	30 minutes	Evaluation of discriminative capability of impulse oscillometry
Discrimination ventilation heterogeneity	30 minutes	Evaluation of discriminative capability of multiple breath washout