NCT00949195

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 21, 2011

Status Verified

October 1, 2009

Enrollment Period

3 months

First QC Date

July 29, 2009

Last Update Submit

July 20, 2011

Conditions

COPD PatientsHealthy SubjectsSemi-supine Echo (SSE)Flow-mediated Vasodilatation (FMD)High Sensitive C-reactive Protein (hsCRP)

Keywords

COPDhealthy patientsPAPCPXSSEhsCRPFMD

Outcome Measures

Primary Outcomes (1)

  • The degree of pulmonary artery pressure change during exercise?

    2 months

Secondary Outcomes (1)

  • Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction?

    2 months

Study Arms (2)

COPD patients

COPD patients with severe obstruction performed the tests.

Other: Measure pulmonary artery pressure change during exerciseOther: Pulmonary pressure response during exercise

Healthy subjects

Age-matched healthy subjects performed the same test also.

Other: Measure pulmonary artery pressure change during exerciseOther: Pulmonary pressure response during exercise

Interventions

Measure pulmonary artery pressure change during exerciseOTHER

Semi-supine echocardiography test

Also known as: lung function, CPX, HsCRP
COPD patientsHealthy subjects
Pulmonary pressure response during exerciseOTHER

Semi-supine echocardiography test

Also known as: Complete lung function, CPX, HsCRP
COPD patientsHealthy subjects

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COPD patients (age between 45 and 70) with moderate to severe obstruction (FEV1\<60%) and healthy subjects (age between 45 and 70)

You may qualify if:

  • 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%

You may not qualify if:

  • Not in the age range
  • Different FEV1 value
  • Severe comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pulmonology, Szeged University

Deszk, Csongrád megye, 6772, Hungary

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27019674DERIVED

Biospecimen

Retention: NONE RETAINED

Blood sample is taken to analyse the systemic inflammatory marker (hsCRP) level from serum. We measure the samples and than we don't store it.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

VentilationC-Reactive Protein

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, ControlledEnvironmentEnvironment and Public HealthAlbuminsProteinsAmino Acids, Peptides, and ProteinsAcute-Phase ProteinsBlood ProteinsImmunoproteins

Study Officials

  • Attila Somfay, MD, PhD

    Department of Pulmonology, Szeged University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Attila Somfay, MD, PhD

CONTACT

+36-62-571-551somfay@deszk.szote.u-szeged.hu

Janos Varga, MD

CONTACT

+36-62-571-527, +36209204235janosvargaster@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2011

Last Updated

July 21, 2011

Record last verified: 2009-10

Locations

HU(1)