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Pulmonary Arterial Hypertension in Systemic Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by IRCCS Policlinico S. Matteo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT00617487
First received: February 6, 2008
Last updated: August 3, 2009
Last verified: August 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the role of stress echocardiography, compared to standard echocardiography in the early identification of pulmonary arterial hypertension in systemic sclerosis. To evaluate the role of BNP in this setting.To analyze data recorded with respect to the parameters commonly used for SSc evaluation (eg thorax HRCT, pulmonary function tests + DLCO, nailfold capillaroscopy, etc); these parameters are available starting for 1999.


Condition
Systemic Sclerosis
Pulmonary Arterial Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Echocardiography in the Early Identification of Pulmonary Arterial Hypertension in Systemic Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS Policlinico S. Matteo:

Estimated Enrollment: 200
Study Start Date: December 2007
Estimated Study Completion Date: January 2010
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with systemic sclerosis

Criteria

Inclusion Criteria:

  • Patients with systemic sclerosis according to LeRoy criteria

Exclusion Criteria:

  • Pregnancy
  • Significant valvular disease
  • Low left ventricular function upon echocardiography (ejection fraction<55%)
  • History of atrial fibrillation, myocardial infarction, pulmonary thromboembolisms, neoplasia or severe hepatic disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617487

Contacts
Contact: Lorenzo Cavagna, MD 00390382501878 lorenzo.cavagna@unipv.it

Locations
Italy
IRCCS Foundation Policlinico S. Matteo Recruiting
Pavia, PV, Italy, 27100
Contact: Lorenzo Cavagna, MD     00390382 ext 501878     lorenzo.cavagna@unipv.it    
IRCCS Policlinico S. Matteo Recruiting
Pavia, PV, Italy, 27100
Principal Investigator: Stefano Ghio, MD            
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
Study Director: Stefano Ghio, MD IRCCS Foundation Policlinico S. Matteo, Cardiology
Principal Investigator: Lorenzo Cavagna, MD University and IRCCS Foundation Policlinico S. Matteo, Rheumatology
  More Information

No publications provided

Responsible Party: Dr Ghio Stefano, Cardiology Unit IRCCS Foundation Policlinico S. Matteo, Pavia
ClinicalTrials.gov Identifier: NCT00617487     History of Changes
Other Study ID Numbers: EchostressSSc
Study First Received: February 6, 2008
Last Updated: August 3, 2009
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Lung Diseases
 Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013