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NCT03667794 Clinical Trial

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

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03667794
Other study ID # MBW-PH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2015
Est. completion date July 31, 2017

Study information
Verified date September 2018
Source Universitätsmedizin Mannheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date July 31, 2017
Est. primary completion date July 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- known or first diagnosis of PH

Exclusion Criteria:

- inability to perform lung function testing

- unable or unwilling to participate

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• body plethysmography
measurement of conventional lung function parameters
• impulse oscillometry
measurement of central and peripheral airway resistance
• multiple breath washout
measurement of ventilation heterogeneity

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitätsmedizin Mannheim

Outcome
Type Measure Description Time frame Safety issue
Primary LCI between-group difference in lung clearance index (LCI) 30 minutes
Primary D5-20 between-group difference in frequency dependence of resistance (D5-20) 30 minutes
Secondary Discrimination small airway resistance Evaluation of discriminative capability of impulse oscillometry 30 minutes
Secondary Discrimination ventilation heterogeneity Evaluation of discriminative capability of multiple breath washout 30 minutes
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