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Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases

This study is currently recruiting participants.
Verified July 2012 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01387035
First received: June 29, 2011
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

The purposes of this study are (I), to evaluate various screening methods for their ability to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.


Condition Phase
Connective Tissue Disease
Pulmonary Hypertension
 Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Correlate Spiroergometric, lung functional Magnetic Resonance Imaging (MRI) and echocardiographic parameters with invasive hemodynamic findings collected by right heart catheterization: which other non-invasive parameters can be found to detect pulmonary hypertension? Can pulmonary hypertension be detected at rest in the echocardiography? In which patients can only stress-Doppler echocardiography confirm manifest or latent pulmonary hypertension? Is stress-Doppler echocardiography a suitable for early detection of pulmonary hypertension in patients with collagen vascular disease?


Secondary Outcome Measures:
  • Subdivision of patients with connective tissue disease in different degrees of severity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Can spiroergometric findings help to subdivide patients with connective tissue diseases into groups according to degrees of severity, and differ the patients based on spiroergometric findings? To what extent is this distinction comparable with the classifications for the "functional classes" (application for PH according to the New York Heart Association (NYHA) classification)


Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Included are all patients who fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR) and who are 18 years or older.

Criteria

Inclusion Criteria:

  • consent form
  • men and women> 18 years
  • fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR)

Exclusion Criteria:

  • all contraindications for exercise testing
  • significant restriction of the left ventricle, unstable coronary artery disease and myocardial infarction in the last 6 months
  • patients with other lung diseases (as the pulmonary infestations as part of systemic disease) or related musculoskeletal disorders influencing baseline exercise capacity
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387035

Contacts
Contact: Christian Nagel, MD +49 6221 396 8063 christian.nagel@thoraxklinik-heidelberg.de
Contact: Ekkehard Grünig, Professor +49 6221 396 8053 ekkehard.gruenig@thoraxklinik-heidelberg.de

Locations
Germany
Center for pulmonary Hypertension, Thoraxclinic Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Christian Nagel, MD     +49 6221 396 8063     christian.nagel@thoraxklinik-heidelberg.de    
Contact: Ekkehard Grünig, Professor     +49 6221 396 8053     ekkehard.gruenig@thoraxklinik-heidelberg.de    
Principal Investigator: Christian Nagel, MD            
Sponsors and Collaborators
University of Heidelberg
Investigators
Study Director: Christian Nagel, MD Center for pulmonary hypertension, Thoraxclinic Heidelberg
Study Director: Ekkehard Grünig, Professor Center for pulmonary hypertension, Thoraxclinic Heidelberg
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01387035     History of Changes
Other Study ID Numbers: S-360/2009
Study First Received: June 29, 2011
Last Updated: July 2, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Connective Tissue Diseases
Hypertension
Hypertension, Pulmonary
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013