Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Novel Screening Strategies for Scleroderma PAH

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Scott Visovatti, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01959815
First received: October 8, 2013
Last updated: October 9, 2013
Last verified: October 2013

October 8, 2013
October 9, 2013
October 2013
October 2018   (final data collection date for primary outcome measure)
Development of pulmonary arterial hypertension [ Time Frame: Two years after enrollment. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01959815 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Novel Screening Strategies for Scleroderma PAH
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided

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
Not Provided
  • Scleroderma and diagnosed PAH
  • "Low risk" scleroderma
  • Healthy volunteers
  • "High risk" scleroderma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
October 2018   (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).
Both
30 Years and older
Yes
Contact: Aileen Patel, BSN 866-963-3587 cvc-ph-research@med.umich.edu
United States
 
NCT01959815
HUM00074818
Yes
Scott Visovatti, MD, University of Michigan
University of Michigan
Not Provided
Not Provided
University of Michigan
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP