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

September 12, 2018 updated by: Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

PH group: known or first diagnosis of PH

Healthy controls: 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: stable pulmonary comorbidities including COPD, sarcoidosis, asthma, or fibrosis as well as non-pulmonary comorbidities.

Description

Inclusion Criteria:

  • known or first diagnosis of PH

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PH patients
Patients with known or first diagnosis of PH
Diagnostic test: body plethysmography
measurement of conventional lung function parameters
Diagnostic test: impulse oscillometry
measurement of central and peripheral airway resistance
Diagnostic test: multiple breath washout
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.
Diagnostic test: body plethysmography
measurement of conventional lung function parameters
Diagnostic test: impulse oscillometry
measurement of central and peripheral airway resistance
Diagnostic test: multiple breath washout
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.
Diagnostic test: body plethysmography
measurement of conventional lung function parameters
Diagnostic test: impulse oscillometry
measurement of central and peripheral airway resistance
Diagnostic test: multiple breath washout
measurement of ventilation heterogeneity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LCI
Time Frame: 30 minutes
between-group difference in lung clearance index (LCI)
30 minutes
D5-20
Time Frame: 30 minutes
between-group difference in frequency dependence of resistance (D5-20)
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discrimination small airway resistance
Time Frame: 30 minutes
Evaluation of discriminative capability of impulse oscillometry
30 minutes
Discrimination ventilation heterogeneity
Time Frame: 30 minutes
Evaluation of discriminative capability of multiple breath washout
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Investigators

  • Principal Investigator: Frederik Trinkmann, MD, Universitätsmedizin Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

September 6, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBW-PH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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