Condition category
Musculoskeletal Diseases
Date applied
16/01/2009
Date assigned
27/02/2009
Last edited
27/02/2009
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

F.-Loeffler-Strasse 23a
Greifswald
17475
Germany

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

http://www.actelion.com

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

Publication citations

Additional files

Editorial Notes