- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00617487
Pulmonary Arterial Hypertension in Systemic Sclerosis
March 6, 2018 updated by: Carlomaurizio Montecucco, IRCCS Policlinico S. Matteo
Stress Echocardiography in the Early Identification of Pulmonary Arterial Hypertension in Systemic Sclerosis
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
PV
-
Pavia, PV, Italy, 27100
- IRCCS Policlinico S. Matteo
-
Pavia, PV, Italy, 27100
- IRCCS Foundation Policlinico S. Matteo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with systemic sclerosis
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
January 1, 2020
Study Registration Dates
First Submitted
February 6, 2008
First Submitted That Met QC Criteria
February 15, 2008
First Posted (Estimate)
February 18, 2008
Study Record Updates
Last Update Posted (Actual)
March 7, 2018
Last Update Submitted That Met QC Criteria
March 6, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Connective Tissue Diseases
- Hypertension, Pulmonary
- Sclerosis
- Hypertension
- Scleroderma, Systemic
- Scleroderma, Diffuse
- Pulmonary Arterial Hypertension
- Familial Primary Pulmonary Hypertension
Other Study ID Numbers
- EchostressSSc
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Systemic Sclerosis
-
AmgenEnrolling by invitationDiffuse Cutaneous Systemic Sclerosis | Sclerosis, SystemicKorea, Republic of, France, United States, Spain, Mexico, Japan, Argentina, Greece, Israel
-
AmgenRecruitingDiffuse Cutaneous Systemic Sclerosis | Sclerosis, SystemicNetherlands, Spain, Germany, United States, Japan, France, Italy, Korea, Republic of, Portugal, Israel, Greece, Argentina, Austria, Mexico, Poland, Switzerland, United Kingdom, Romania, Chile
-
Michael M. PhamTerminatedSystemic Sclerosis | Scleroderma, Systemic | Scleroderma, Diffuse | Diffuse Cutaneous Systemic Sclerosis | Interstitial Lung Disease | Scleroderma | Systemic Sclerosis, Diffuse | Diffuse Systemic Sclerosis | Pulmonary Fibrosis Interstitial | Diffuse Scleroderma | Diffuse Cutaneous Scleroderma | Progressive Systemic... and other conditionsUnited States
-
University of ManchesterCompletedEarly Diffuse Cutaneous Systemic Sclerosis
-
Fred Hutchinson Cancer CenterNational Institute of Allergy and Infectious Diseases (NIAID)CompletedSystemic Scleroderma | Severe Systemic SclerosisUnited States
-
Kadmon, a Sanofi CompanyTerminatedDiffuse Cutaneous Systemic Sclerosis | System; SclerosisUnited States
-
Kyverna TherapeuticsNot yet recruitingSystemic Sclerosis | Systemic Sclerosis - Diffuse Cutaneous | Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
-
Boston UniversityCompleted
-
Federal University of São PauloUnknown
-
Lawson Health Research InstituteMallinckrodtNot yet recruitingDiffuse Cutaneous Systemic SclerosisCanada