Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01-09
Study information
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
Acronym
Study hypothesis
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
Ethics Committee of the Ernst Moritz Arndt University of Greifswald, pending as of 16/01/2009.
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
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
Phase
Not Applicable
Drug names
Primary outcome measures
Exercise capacity
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/06/2009
Overall trial end date
31/05/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults >=18 years, both males and females
2. Patients with all forms of CTD
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/06/2009
Recruitment end date
31/05/2010
Locations
Countries of recruitment
Germany
Trial participating centre
F.-Loeffler-Strasse 23a
Greifswald
17475
Germany
Sponsor information
Organisation
Actelion (Germany)
Sponsor details
Munzinger Str. 1
Freiburg
79111
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Actelion (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