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Novel Screening Strategies for Scleroderma PAH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01959815
Recruitment Status : Recruiting
First Posted : October 10, 2013
Last Update Posted : September 19, 2017
Information provided by (Responsible Party):

October 8, 2013
October 10, 2013
September 19, 2017
October 2013
October 2020   (Final data collection date for primary outcome measure)
Development of pulmonary arterial hypertension [ Time Frame: Two years after enrollment. ]
Same as current
Complete list of historical versions of study NCT01959815 on ClinicalTrials.gov Archive Site
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Novel Screening Strategies for Scleroderma PAH
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Patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). It is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. However, the tests that we now use to find the earliest form of this disease in scleroderma patients are not good enough. This study will examine whether tests performed during exercise can improve our ability to find early pulmonary arterial hypertension. The study will also try to identify genes that are responsible for the development of pulmonary arterial hypertension.
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Observational Model: Cohort
Time Perspective: Prospective
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Blood samples will be drawn at rest and during exercise.
Probability Sample
Volunteers will be recruited from scleroderma clinics, pulmonary hypertension clinics, and (for healthy volunteers) the Ann Arbor area.
  • Pulmonary Arterial Hypertension
  • Scleroderma
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  • Scleroderma and diagnosed PAH
  • "Low risk" scleroderma
  • Healthy volunteers
  • "High risk" scleroderma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2020
October 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 30 years or older;
  • diagnosis of limited or diffuse scleroderma (American College of Rheumatology criteria)
  • for the "high risk" group, one of the following features:

    • resting transthoracic echocardiogram showing elevated right-sided pressures within previous 3 months [tricuspid regurgitation (TR) jet >2.8 m/s or evidence of right ventricular dysfunction]
    • pulmonary function testing (PFT) showing abnormal diffusing capacity of carbon monoxide (DLCO) not due to significant interstitial lung disease (DLCO<60% predicted or FVC: DLCO ratio >1.4)

Exclusion Criteria:

  • Pregnancy
  • prior diagnosis of pulmonary hypertension
  • treatment with endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogues
  • previous diagnosis of obstructive lung disease or pulmonary thromboembolic disease
  • current smoker
  • significant valvular disease
  • resting echocardiogram showing left ventricular ejection fraction<50% within previous 3 months
  • resting echocardiogram showing significant (greater than Grade I) diastolic dysfunction
  • pulmonary emboli (past or present).
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
Contact: Ann Johnson, BSN 866-963-3587 cvc-ph-research@med.umich.edu
United States
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Scott Visovatti, MD, University of Michigan
University of Michigan
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University of Michigan
September 2017