Condition category
Respiratory
Date applied
14/10/2008
Date assigned
20/11/2008
Last edited
11/02/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ralf Ewert

ORCID ID

Contact details

Ernst Moritz Arndt University Greifswald
Department of Internal Medicine
Pulmonary Medicine and Infectious Diseases
Friedrich Loeffler Strasse 23a
Greifswald
17475
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Cardiopulmonary exercise testing and haemodynamics in patients with chronic obstructive pulmonary disease: an observational cross-sectional study

Acronym

Study hypothesis

1. Gas exchange data assessed by cardiopulmonary exercise testing (CPET) will provide profound prognostic and clinically relevant data to sub-classify patients with severe chronic obstructive pulmonary disease (COPD)
2. Noninvasive cardiopulmonary exercise characteristics correlate to invasively measured haemodynamics obtained by right heart catheterisation
3. Cardiopulmonary exercise measures provide substantial prognostic properties above invasive measures and lung function abnormalities

Please note that as of 11/02/2009 this record was updated to include amended trial dates. The initial trial dates at the time of registration were:
Initial anticipated start date: 01/01/2009
Initial anticipated end date: 30/06/2010

Ethics approval

Added 11/02/2009: University of Greifswald ethics committee gave approval on the 20th November 2008 (ref: BB 96/08)

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Patients suffering from COPD (according to the GOLD criteria classified as stage III and IV) will undergo CPET according to a standardised exercise protocol. In addition to the previous obtained spirometric and body plethysmographic data, a number of CPET data will be investigated.

Based on this CPET data the aim of the study is to sub-classify patients into clinical and prognostic groups. The data of gas exchange during exercise might provide further insights in the exercise limiting disease related factors. The impact of the data might result in a new sub-classification of patients with severe COPD.

Depending on the investigators opinion right heart catheterisation can be applied in cases of suspected pulmonary hypertension.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Exercise variables
2. Lung function data
3. Haemodynamic measures obtained by right heart catheterisation

Primary and secondary outcomes will be assessed at the end of the study.

Secondary outcome measures

1. GOLD stage
2. Mortality

Primary and secondary outcomes will be assessed at the end of the study.

Overall trial start date

01/04/2009

Overall trial end date

30/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of COPD (according to American Thoracic Society [ATS] case definition) meeting all necessary criteria to be classified as Global Initiative for chronic Obstructive Lung Disease (GOLD) III and IV
2. Informed consent for study-related procedure
3. Stable medications for the last two weeks
4. Ability to safely perform the CPET without contraindications
5. Aged 18 - 80 years, both genders

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Existing contraindication for exercise test
2. Patients with clinically relevant congestive heart failure or other diseases which may influence the results of the study (e.g. handicaps)
3. Exacerbation of COPD within the last two weeks before CPET
4. Conditions associated with poor compliance
5. Patients who have participated in a clinical study within the last four weeks

Recruitment start date

01/04/2009

Recruitment end date

30/10/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Ernst Moritz Arndt University Greifswald
Greifswald
17475
Germany

Sponsor information

Organisation

DOCxcellence GmbH (Germany)

Sponsor details

Wattstrasse 11-13
Berlin
13355
Germany

Sponsor type

Industry

Website

http://www.docxcellence.de

Funders

Funder type

Industry

Funder name

DOCxcellence GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes