Pulmonary HypertensionNCT03667794
Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)
An observational study of Pulmonary Hypertension, run by Universitätsmedizin Mannheim.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- body plethysmography, impulse oscillometry and multiple breath washout
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 31 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- known or first diagnosis of PH
Who cannot join
- inability to perform lung function testing
- unable or unwilling to participate
About this study
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
- Being tested
- body plethysmography, impulse oscillometry, multiple breath washout
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body plethysmographyDiagnostic test
measurement of conventional lung function parameters
impulse oscillometryDiagnostic test
measurement of central and peripheral airway resistance
multiple breath washoutDiagnostic test
measurement of ventilation heterogeneity
| Study group | Role | What they receive |
|---|---|---|
| PH patients | Patients with known or first diagnosis of PH Receives: 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. Receives: 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. Receives: Diagnostic Test: body plethysmography; Diagnostic Test: impulse oscillometry; Diagnostic Test: multiple breath washout |
What is being measured
The primary outcome is the main question the study is designed to answer.
LCI
between-group difference in lung clearance index (LCI)
Measured: 30 minutes
D5-20
between-group difference in frequency dependence of resistance (D5-20)
Measured: 30 minutes
Secondary outcomes (2)
Discrimination small airway resistance
Evaluation of discriminative capability of impulse oscillometry
Measured: 30 minutes
Discrimination ventilation heterogeneity
Evaluation of discriminative capability of multiple breath washout
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Jul 2015
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
- Investigators
- Frederik Trinkmann, MD, Principal investigator, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667794
- Sponsor's protocol ID
- MBW-PH
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)
- ClinicalTrials.gov ID
- NCT03667794
- Acronym / sponsor ID
- MBW-PH
- Conditions
- Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PH patients | – | Diagnostic Test: body plethysmography, Diagnostic Test: impulse oscillometry, Diagnostic Test: multiple breath washoutPatients with known or first diagnosis of PH |
| healthy controls | – | Diagnostic Test: body plethysmography, Diagnostic Test: impulse oscillometry, Diagnostic Test: multiple breath washoutHealthy 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 | – | Diagnostic Test: body plethysmography, Diagnostic Test: impulse oscillometry, Diagnostic Test: multiple breath washoutNon-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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- known or first diagnosis of PH
Key exclusion criteria (2 listed)
- inability to perform lung function testing
- unable or unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body plethysmographymeasurement of conventional lung function parameters | Diagnostic test | PH patients, healthy controls, non-healthy controls |
| impulse oscillometrymeasurement of central and peripheral airway resistance | Diagnostic test | PH patients, healthy controls, non-healthy controls |
| multiple breath washoutmeasurement of ventilation heterogeneity | Diagnostic test | PH patients, healthy controls, non-healthy controls |
Primary outcome
LCI
Time frame: 30 minutes
between-group difference in lung clearance index (LCI)
D5-20
Time frame: 30 minutes
between-group difference in frequency dependence of resistance (D5-20)
2 secondary outcomes
Discrimination small airway resistance
Time frame: 30 minutes
Discrimination ventilation heterogeneity
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederik Trinkmann, MD principal investigator
Universitätsmedizin Mannheim
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Universitätsmedizin Mannheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LCI (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.