Pulmonary Arterial Pressure Response During Exercise

NCT ID: NCT00949195

Last Updated: 2011-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-12-31

Brief Summary

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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:

1. The degree of right ventricular function change during exercise?
2. Is endothel dysfunction manifested with pulmonary artery pressure rise?
3. What is the correlation between the systemic inflammatory marker hsCRP and the degree of pulmonary artery pressure rise?

Detailed Description

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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

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COPD Patients Healthy Subjects Semi-supine Echo (SSE) Flow-mediated Vasodilatation (FMD) High Sensitive C-reactive Protein (hsCRP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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COPD patients

COPD patients with severe obstruction performed the tests.

Measure pulmonary artery pressure change during exercise

Intervention Type OTHER

Semi-supine echocardiography test

Pulmonary pressure response during exercise

Intervention Type OTHER

Semi-supine echocardiography test

Healthy subjects

Age-matched healthy subjects performed the same test also.

Measure pulmonary artery pressure change during exercise

Intervention Type OTHER

Semi-supine echocardiography test

Pulmonary pressure response during exercise

Intervention Type OTHER

Semi-supine echocardiography test

Interventions

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Measure pulmonary artery pressure change during exercise

Semi-supine echocardiography test

Intervention Type OTHER

Pulmonary pressure response during exercise

Semi-supine echocardiography test

Intervention Type OTHER

Other Intervention Names

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lung function, CPX, HsCRP Complete lung function, CPX, HsCRP

Eligibility Criteria

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Inclusion Criteria

* 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%

Exclusion Criteria

* Not in the age range
* Different FEV1 value
* Severe comorbidities
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Szeged University

OTHER

Sponsor Role lead

Responsible Party

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Department of Pulmonology, Szeged University

Principal Investigators

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Attila Somfay, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pulmonology, Szeged University

Locations

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Department of Pulmonology, Szeged University

Deszk, Csongrád megye, Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Attila Somfay, MD, PhD

Role: CONTACT

+36-62-571-551

Janos Varga, MD

Role: CONTACT

+36-62-571-527, +36209204235

Facility Contacts

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Attila Somfay, MD, PhD

Role: primary

+36-62-571-552

Janos Varga, MD

Role: backup

+36-62-571-527, +36209204235

References

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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.

Reference Type DERIVED
PMID: 27019674 (View on PubMed)

Other Identifiers

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ISRCTN11034505

Identifier Type: -

Identifier Source: secondary_id

SZTE PULM-PAHP

Identifier Type: -

Identifier Source: org_study_id

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