Cardiopulmonary exercise testing and haemodynamics in patients with chronic obstructive pulmonary disease
| ISRCTN | ISRCTN18993812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18993812 |
| Protocol serial number | N/A |
| Sponsor | DOCxcellence GmbH (Germany) |
| Funder | DOCxcellence GmbH (Germany) |
- Submission date
- 14/10/2008
- Registration date
- 20/11/2008
- Last edited
- 11/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ralf Ewert
Scientific
Scientific
Ernst Moritz Arndt University Greifswald
Department of Internal Medicine
Pulmonary Medicine and Infectious Diseases
Friedrich Loeffler Strasse 23a
Greifswald
17475
Germany
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional study |
| Secondary study design | Cross-section survey |
| Study type | Participant information sheet |
| Scientific title | Cardiopulmonary exercise testing and haemodynamics in patients with chronic obstructive pulmonary disease: an observational cross-sectional study |
| Study objectives | 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(s) | Added 11/02/2009: University of Greifswald ethics committee gave approval on the 20th November 2008 (ref: BB 96/08) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | 1. GOLD stage 2. Mortality Primary and secondary outcomes will be assessed at the end of the study. |
| Completion date | 30/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 30/10/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Ernst Moritz Arndt University Greifswald
Greifswald
17475
Germany
17475
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
