Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc) (DETECT)
This study has been terminated.
Information provided by (Responsible Party):
First received: June 25, 2008
Last updated: June 21, 2012
Last verified: June 2012
A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension
Pulmonary Arterial Hypertension
||Observational Model: Cohort
Time Perspective: Prospective
||A Two-stage Prospective Observational Cohort Study in Scleroderma Patients to Evaluate Screening Tests and the Incidence of Pulmonary Arterial Hypertension and Pulmonary Hypertension
Primary Outcome Measures:
- Pulmonary arterial hypertension (PAH) confirmed by right heart catheterization (RHC) [ Time Frame: Baseline and 3-year follow-up ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Pulmonary hypertension (PH) confirmed by right heart catheterization (RHC) [ Time Frame: Baseline and 3-year follow-up ] [ Designated as safety issue: No ]
Serum and plasma samples will be stored at a central laboratory for at least two additional years after official study termination.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with scleroderma in USA, Canada, UK, Germany, Switzerland, Austria, The Netherlands, Belgium, Sweden, Slovakia, and Turkey.
- Male or female
- Age ≥ 18 years
- Patients with definite diagnosis of SSc by American College of Rheumatology (ACR) criteria (18); including all patients with any other connective tissue diseases (CTD) who, in parallel, meet the ACR criteria for SSc (18)
- SSc disease duration > 3 years dated from onset of first non-Raynaud feature
- Diffusing capacity of the lung for carbon monoxide (DLCO) < 60% of predicted
Patients with clinically relevant left heart disease as defined above, diagnosed by ECHO at baseline (i.e. after enrolment), will be included in the study.
Additional exclusion criteria after patient enrolment
- During the study, use of therapy that is considered definite PAH/PH treatment (19) is prohibited and will result in discontinuation of the patient from the study, unless the total treatment duration per year is less than 6 weeks. Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted.
- During the study, use of therapy that is considered definite PAH/PH treatment (19) is prohibited within the 6 weeks preceding the follow-up visits. Violation of this rule will result in discontinuation of the patient from the study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706082
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 25, 2008
||June 21, 2012
||United States: Institutional Review Board
Canada: Ethics Review Committee
United Kingdom: Research Ethics Committee
Germany: Ethics Commission
Netherlands: Independent Ethics Committee
Belgium: Institutional Review Board
Sweden: Institutional Review Board
Turkey: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Respiratory Tract Diseases
Connective Tissue Diseases