COPD PatientsPAPCOPDHSNCT00949195
Pulmonary Arterial Pressure Response During Exercise
An observational study of COPD Patients and Healthy Subjects, run by Szeged University at 1 site in Hungary.
Trial summary
Background: The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise and flow-mediated vasodilatation measurement may give useful data in the rehabilitation… Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD Patients, Healthy Subjects, Semi-supine Echo (SSE)
- What is being tested?
- Measure pulmonary artery pressure change during exercise and Pulmonary pressure response during exercise
- How many people
- 80 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2009to Dec 2011
- 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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD patients (age between 45 and 70) with moderate to severe obstruction (FEV1<60%) and healthy subjects (age between 45 and 70)
Who may be able to join
- COPD patients (age between 45 and 70)
- with moderate to severe obstruction (FEV1<60%pred) and
- healthy subjects (age between 45 and 70, (FEV1>80%pred, FEV1/FVC>70%
Who cannot join
- Not in the age range
- Different FEV1 value
- Severe comorbidities
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Department of Pulmonology, Szeged University
Deszk, Csongrád megye, 6772
Attila Somfay, MD, PhD, +36-62-571-552, somfay@deszk.szote.u-szeged.hu
Janos Varga, MD, +36-62-571-527, +36209204235, janosvargaster@gmail.com
About this study
Official title: Pulmonary Arterial Pressure Response During Exercise in COPD and Healthy Subjects
Background:
The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.
Read more
Methods:
Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.
Primary endpoint:
The degree of pulmonary artery systolic pressure change during exercise?
Secondary endpoint:
- The degree of right ventricular function change during exercise?
- Is endothel dysfunction manifested with pulmonary artery pressure rise?
- What is the correlation between the systemic inflammatory marker hsCRP and the degree of pulmonary artery pressure rise?
Read the detailed description
Background: The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise by semi-supine echocardiography and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.
Methods: Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. All of the subjects perform complete lung function with body pletysmography and diffusion capacity measurement. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.
- Conditions
- COPD Patients, Healthy Subjects, Semi-supine Echo (SSE), Flow-mediated Vasodilatation (FMD), High Sensitive C-reactive Protein (hsCRP)
- Being tested
- Measure pulmonary artery pressure change during exercise, Pulmonary pressure response during exercise
- Keywords
- COPD, healthy patients, PAP, CPX, SSE, hsCRP, FMD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure pulmonary artery pressure change during exerciseOther
Also called lung function, CPX, HsCRP
Semi-supine echocardiography test
Pulmonary pressure response during exerciseOther
Also called Complete lung function, CPX, HsCRP
Semi-supine echocardiography test
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | COPD patients with severe obstruction performed the tests. Receives: Other: Measure pulmonary artery pressure change during exercise; Other: Pulmonary pressure response during exercise | |
| Healthy subjects | Age-matched healthy subjects performed the same test also. Receives: Other: Measure pulmonary artery pressure change during exercise; Other: Pulmonary pressure response during exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pulmonary artery pressure change during exercise?
Measured: 2 months
Secondary outcomes (1)
Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction?
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD PatientsStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Investigators
- Attila Somfay, MD, PhD, Principal investigator, Department of Pulmonology, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949195
- Sponsor's protocol ID
- SZTE PULM-PAHP
- Other IDs
- ISRCTN11034505
- Acronym
- PAPCOPDHS
- Status last verified
- Oct 2009
- First submitted
- 29 Jul 2009
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Varga J, Palinkas A, Lajko I, Horvath I, Boda K, Somfay A. Pulmonary Arterial Pressure Response During Exercise in COPD: A Correlation with C-Reactive Protein (hsCRP). Open Respir Med J. 2016 Jan 29;10:1-11. doi: 10.2174/1874306401610010001. eCollection 2016.
PubMed 27019674
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Arterial Pressure Response During Exercise in COPD and Healthy Subjects
- ClinicalTrials.gov ID
- NCT00949195
- Acronym / sponsor ID
- PAPCOPDHS / SZTE PULM-PAHP
- Conditions
- COPD Patients, Healthy Subjects, Semi-supine Echo (SSE), Flow-mediated Vasodilatation (FMD), High Sensitive C-reactive Protein (hsCRP)
- Keywords
- COPD, healthy patients, PAP, CPX, SSE, hsCRP, FMD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2009
- Study completion
- Dec 2011 (estimated)
- First posted
- 30 Jul 2009 (estimated)
- 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.
Background:
The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.
Methods:
Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.
Primary endpoint:
The degree of pulmonary artery systolic pressure change during exercise?
Secondary endpoint:
- The degree of right ventricular function change during exercise?
- Is endothel dysfunction manifested with pulmonary artery pressure rise?
- What is the correlation between the systemic inflammatory marker hsCRP and the degree of pulmonary artery pressure rise?
Detailed description
Background: The extent of increase in systolic pulmonary arterial pressure (PAPs) during exercise in patients with COPD is unpredictable from lung function data. The non-invasive assessment of pulmonary hemodynamics during exercise by semi-supine echocardiography and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of COPD patients.
Methods: Patients with stable, severe COPD and healthy, age-matched subjects (H) perform semi supine echocardiography with PAPs measurement. COPD patients perform ramp protocol with gas exchange detection. Serum hsCRP level is also determined in COPD patients. All of the subjects perform complete lung function with body pletysmography and diffusion capacity measurement. Endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with Doppler ultrasonography.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: Measure pulmonary artery pressure change during exercise, Other: Pulmonary pressure response during exerciseCOPD patients with severe obstruction performed the tests. |
| Healthy subjects | – | Other: Measure pulmonary artery pressure change during exercise, Other: Pulmonary pressure response during exerciseAge-matched healthy subjects performed the same test also. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients (age between 45 and 70) with moderate to severe obstruction (FEV1<60%) and healthy subjects (age between 45 and 70)
Key inclusion criteria (3 listed)
- COPD patients (age between 45 and 70)
- with moderate to severe obstruction (FEV1<60%pred) and
- healthy subjects (age between 45 and 70, (FEV1>80%pred, FEV1/FVC>70%
Key exclusion criteria (3 listed)
- Not in the age range
- Different FEV1 value
- Severe comorbidities
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 |
|---|---|---|
| Measure pulmonary artery pressure change during exerciseAlso: lung function, CPX, HsCRPSemi-supine echocardiography test | Other | COPD patients, Healthy subjects |
| Pulmonary pressure response during exerciseAlso: Complete lung function, CPX, HsCRPSemi-supine echocardiography test | Other | COPD patients, Healthy subjects |
Primary outcome
The degree of pulmonary artery pressure change during exercise?
Time frame: 2 months
1 secondary outcome
Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction?
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
- Derived from this study: PubMed 27019674Varga J, Palinkas A, Lajko I, Horvath I, Boda K, Somfay A. Pulmonary Arterial Pressure Response During Exercise in COPD: A Correlation with C-Reactive Protein (hsCRP). Open Respir Med J. 2016 Jan 29;10:1-11. doi: 10.2174/1874306401610010001. eCollection 2016.
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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.
Attila Somfay, MD, PhD principal investigator
Department of Pulmonology, Szeged University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Patients and Healthy Subjects, run by Szeged University at 1 site in Hungary.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Attila Somfay, MD, PhD (+36-62-571-551, somfay@deszk.szote.u-szeged.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of pulmonary artery pressure change during exercise? (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00949195, which also lists 1 linked publication.
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 21 Jul 2011.