Cardiopulmonary exercise testing and stress echocardiography as screening methods to detect pulmonary hypertension in patients with connective tissue diseases (CTD)
| ISRCTN | ISRCTN96212539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96212539 |
| Protocol serial number | 01-09 |
| Sponsor | Actelion (Germany) |
| Funder | Actelion (Germany) |
- Submission date
- 16/01/2009
- Registration date
- 27/02/2009
- Last edited
- 27/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
F.-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 stress echocardiography as screening methods to detect pulmonary hypertension in patients with connective tissue diseases (CTD): an observational study |
| Study objectives | 1. Cardiopulmonary exercise testing (CPET) and stress echocardiography provide reliable measures to characterise severity stages of patients with connective tissue diseases (CTD) and pulmonary hypertension (PH) 2. CPET and stress echocardiography provide reliable measures for early detection of PH in CTD 3. CPET and stress echocardiography correlates to established severity measures of dyspnoea (World Health Organization [WHO] classification) in patients with CTD and PH |
| Ethics approval(s) | Ethics Committee of the Ernst Moritz Arndt University of Greifswald, pending as of 16/01/2009. |
| Health condition(s) or problem(s) studied | Pulmonary hypertension in patients with connective tissue diseases (CTD) |
| Intervention | Patients affected by different forms of CDT will be included in the study. All patients will undergo CPET as well as stress echocardiography to detect secondary PH. Based on general disease characteristics and CPET results a diagnostic value will be assessed to provide a prospective measure for the early detection of PH in CDT. Second, it will attempted to assess a severity classification based on CPET and stress echocardiography. |
| Intervention type | Other |
| Primary outcome measure(s) |
Exercise capacity |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/05/2010 |
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. Adults >=18 years, both males and females 2. Patients with all forms of CTD |
| Key exclusion criteria | 1. Contraindications for CPET according to current guidelines 2. Congestive heart failure 3. Coronary heart disease 4. Myocardial infarction within the last 6 months 5. Pulomonary diseases other than CTD 6. Primary myopathy |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 31/05/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
F.-Loeffler-Strasse 23a
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 |
