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

NCT ID: NCT03667794

Last Updated: 2018-09-14

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

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PH patients

Patients with known or first diagnosis of PH

body plethysmography

Intervention Type DIAGNOSTIC_TEST

measurement of conventional lung function parameters

impulse oscillometry

Intervention Type DIAGNOSTIC_TEST

measurement of central and peripheral airway resistance

multiple breath washout

Intervention Type DIAGNOSTIC_TEST

measurement of ventilation heterogeneity

healthy controls

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.

body plethysmography

Intervention Type DIAGNOSTIC_TEST

measurement of conventional lung function parameters

impulse oscillometry

Intervention Type DIAGNOSTIC_TEST

measurement of central and peripheral airway resistance

multiple breath washout

Intervention Type DIAGNOSTIC_TEST

measurement of ventilation heterogeneity

non-healthy controls

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.

body plethysmography

Intervention Type DIAGNOSTIC_TEST

measurement of conventional lung function parameters

impulse oscillometry

Intervention Type DIAGNOSTIC_TEST

measurement of central and peripheral airway resistance

multiple breath washout

Intervention Type DIAGNOSTIC_TEST

measurement of ventilation heterogeneity

Interventions

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body plethysmography

measurement of conventional lung function parameters

Intervention Type DIAGNOSTIC_TEST

impulse oscillometry

measurement of central and peripheral airway resistance

Intervention Type DIAGNOSTIC_TEST

multiple breath washout

measurement of ventilation heterogeneity

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* known or first diagnosis of PH

Exclusion Criteria

* inability to perform lung function testing
* unable or unwilling to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Dr. Frederik Trinkmann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frederik Trinkmann, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mannheim

Other Identifiers

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MBW-PH

Identifier Type: -

Identifier Source: org_study_id

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