Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc) (DETECT)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00706082
First received: June 25, 2008
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension


Condition
Systemic Sclerosis
Pulmonary Arterial Hypertension
Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Two-stage Prospective Observational Cohort Study in Scleroderma Patients to Evaluate Screening Tests and the Incidence of Pulmonary Arterial Hypertension and Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Actelion:

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 ]

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 ]

Biospecimen Retention:   Samples Without DNA

Serum and plasma samples will be stored at a central laboratory for at least two additional years after official study termination.


Enrollment: 490
Study Start Date: October 2008
Study Completion Date: March 2012
Primary Completion Date: November 2011 (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:   Non-Probability Sample
Study Population

Patients with scleroderma in USA, Canada, UK, Germany, Switzerland, Austria, The Netherlands, Belgium, Sweden, Slovakia, and Turkey.

Criteria

Inclusion criteria

  • 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

Exclusion criteria

  • PH confirmed by RHC before enrolment, i.e. mean pulmonary arterial pressure (mPAP) > or = 25 mmHg at rest or > or = 30 mmHg at exercise, independent of PCWP (11)
  • RHC within the 12 months before enrolment
  • Use of therapy that is considered definite PAH/PH treatment (19) for any indication, within the 6 weeks before enrolment and/or for a total of more than 6 weeks during the 12 months before enrolment: i.e. endothelin receptor antagonists (ERA; e.g. bosentan, sitaxsentan, ambrisentan), phosphodiesterase type 5 inhibitors (PDE5; e.g. sildenafil, tadalafil, vardenafil), prostanoids (e.g. epoprostenol, treprostinil, iloprost, beraprost), and any experimental PAH/PH drugs. Intermittent use of PDE5 inhibitors for male erectile dysfunction is permitted
  • Forced vital capacity (FVC) < 40%
  • Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 40 ml/min/1.73 m2 (20), assessed according to local practice
  • Previous evidence or previous diagnosis of clinically relevant left heart disease and other relevant conditions, i.e. at least one of the following:

    • Previous ECHO with estimated left ventricular (LV) ejection fraction < 50%, previous history of cardiogenic pulmonary edema, increased size of left atrium (> 50 mm)
    • Known significant diastolic dysfunction associated with clinical heart failure or PCWP > 15mmHg
    • Known significant coronary disease or significant valvular heart disease
    • Evidence of inadequately treated blood pressure, defined as > 160/90 mmHg and/or blood pressure during exercise > 220/120 mmHg (if evaluated)
    • Known hypertrophic cardiomyopathy or left ventricular hypertrophy (interventricular septum thickness (IVS) or posterior wall thickness (PWD) > 1.2 cm)
    • Patients referred with overt heart failure
    • Known congenital heart defects such as single ventricle, transposition, or Eisenmenger physiology
    • Previous closure of systemic pulmonary shunt, heart valve replacement, or cardiac transplantation
  • Pregnancy: pregnancy testing in females with child-bearing potential is mandatory and must be done before enrolment
  • Patients unlikely to be available for annual follow up over an anticipated 3 years of study (e.g. survival estimate, psychological, logistics; based on investigator discretion)

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.
  Contacts and Locations
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

  Show 83 Study Locations
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00706082     History of Changes
Other Study ID Numbers: AC-052-510
Study First Received: June 25, 2008
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
United Kingdom: Research Ethics Committee
Germany: Ethics Commission
Switzerland: Ethikkommission
Austria: Ethikkommission
Netherlands: Independent Ethics Committee
Belgium: Institutional Review Board
Sweden: Institutional Review Board
Turkey: Ethics Committee

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

ClinicalTrials.gov processed this record on September 30, 2014