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

NCT03667794 | Completed DMC

• 1 other identifier: MBW-PH
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• LCI

  between-group difference in lung clearance index (LCI)

  30 minutes

• D5-20

  between-group difference in frequency dependence of resistance (D5-20)

  30 minutes

Secondary Outcomes (2)

• Discrimination small airway resistance

  30 minutes

• Discrimination ventilation heterogeneity

  30 minutes

Study Arms (3)

PH patients

Patients with known or first diagnosis of PH

Diagnostic Test: body plethysmography; Diagnostic Test: impulse oscillometry; Diagnostic Test: multiple breath washout

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; Diagnostic Test: impulse oscillometry; Diagnostic Test: multiple breath washout

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; Diagnostic Test: impulse oscillometry; Diagnostic Test: multiple breath washout

Interventions

body plethysmography DIAGNOSTIC_TEST

measurement of conventional lung function parameters

PH patients; healthy controls; non-healthy controls

impulse oscillometry DIAGNOSTIC_TEST

measurement of central and peripheral airway resistance

PH patients; healthy controls; non-healthy controls

multiple breath washout DIAGNOSTIC_TEST

measurement of ventilation heterogeneity

PH patients; healthy controls; non-healthy controls

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• known or first diagnosis of PH

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Plethysmography, Whole Body

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Plethysmography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Study Officials

• Frederik Trinkmann, MD

  Universitätsmedizin Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 12, 2018
• Study Start: July 1, 2015
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share