Pulmonary Arterial Pressure Response During Exercise | NCT00949195

Studies
Pulmonary Arterial Pressure Response During Exercise

NCT00949195

Sponsor

Szeged University

Status

Unknown status

Last Update Posted

Jul 21, 2011Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

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

Interventions

Measure pulmonary artery pressure change during exercise
Pulmonary pressure response during exercise

Countries

Hungary

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ISRCTN11034505

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2009

Completion Date

Dec 2011Estimated

First Submitted Date

Jul 29, 2009

First Submission Date that Met QC Criteria

Jul 29, 2009

First Posted Date

Jul 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2011

Last Update Posted Date

Jul 21, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD patients		COPD patients with severe obstruction performed the tests.	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.	Other: Measure pulmonary artery pressure change during exercise Other: Pulmonary pressure response during exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measure pulmonary artery pressure change during exercise	Other	Semi-supine echocardiography test	COPD patients Healthy subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The degree of pulmonary artery pressure change during exercise?		2 months

Secondary Outcomes

Measure	Description	Time Frame
Right ventricular function change? Correlation between systemic inflammation (hsCRP) and pulmonary artery pressure change? Endothelial dysfunction?		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

70 Years

Standard Ages

AdultOlder 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)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Attila Somfay, MD, PhD	Contact	+36-62-571-551		somfay@deszk.szote.u-szeged.hu
Janos Varga, MD	Contact	+36-62-571-527, +36209204235		janosvargaster@gmail.com

Overall Officials

Name	Affiliation	Role
Attila Somfay, MD, PhD	Department of Pulmonology, Szeged University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pulmonology, Szeged University	Recruiting	Deszk	Csongrád megye	6772	Hungary

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27019674	Derived	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.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

ID	Term
D014691	Ventilation
D002097	C-Reactive Protein

ID	Term
D004780	Environment, Controlled
D004777	Environment
D004778	Environment and Public Health
D000418	Albumins