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Trial record 1 of 1 for:    NCT01387035
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Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases

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ClinicalTrials.gov Identifier: NCT01387035
Recruitment Status : Recruiting
First Posted : July 4, 2011
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University

Brief Summary:
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 or disease
Connective Tissue Disease Pulmonary Hypertension

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases
Study Start Date : January 2010
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients [ Time Frame: 3 years ]
    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 :
  1. Subdivision of patients with connective tissue disease in different degrees of severity [ Time Frame: 3 years ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387035


Contacts
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Contact: Ekkehard Grünig, MD, Prof. +49 6221 396 8053 ekkehard.gruenig@med.uni-heidelberg.de

Locations
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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
Heidelberg University
Investigators
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Study Director: Christian Nagel, MD Center for pulmonary hypertension, Thoraxclinic Heidelberg
Study Director: Ekkehard Grünig, Professor Center for pulmonary hypertension, Thoraxclinic Heidelberg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, Heidelberg University
ClinicalTrials.gov Identifier: NCT01387035    
Other Study ID Numbers: S-360/2009
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Connective Tissue Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases