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
Secondary identifying numbers 01-09
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

F.-Loeffler-Strasse 23a
Greifswald
17475
Germany

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross-section survey
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCardiopulmonary exercise testing and stress echocardiography as screening methods to detect pulmonary hypertension in patients with connective tissue diseases (CTD): an observational study
Study objectives1. 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) studiedPulmonary hypertension in patients with connective tissue diseases (CTD)
InterventionPatients 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 typeOther
Primary outcome measureExercise capacity
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/06/2009
Completion date31/05/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. Adults >=18 years, both males and females
2. Patients with all forms of CTD
Key exclusion criteria1. 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 enrolment01/06/2009
Date of final enrolment31/05/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

F.-Loeffler-Strasse 23a
Greifswald
17475
Germany

Sponsor information

Actelion (Germany)
Industry

Munzinger Str. 1
Freiburg
79111
Germany

Website http://www.actelion.com
ROR logo "ROR" https://ror.org/03572ah39

Funders

Funder type

Industry

Actelion (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan