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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. Identifier: NCT01959815
Recruitment Status : Recruiting
First Posted : October 10, 2013
Last Update Posted : September 19, 2017
Information provided by (Responsible Party):
Scott Visovatti, MD, University of Michigan

Brief Summary:
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.

Condition or disease
Pulmonary Arterial Hypertension Scleroderma

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2013
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Scleroderma and diagnosed PAH
"Low risk" scleroderma
Healthy volunteers
"High risk" scleroderma

Primary Outcome Measures :
  1. Development of pulmonary arterial hypertension [ Time Frame: Two years after enrollment. ]

Biospecimen Description:
Blood samples will be drawn at rest and during exercise.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Volunteers will be recruited from scleroderma clinics, pulmonary hypertension clinics, and (for healthy volunteers) the Ann Arbor area.

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01959815

Contact: Ann Johnson, BSN 866-963-3587

United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ann Johnson, BSN    866-963-3587   
Principal Investigator: Scott Visovatti, MD         
Sponsors and Collaborators
University of Michigan

Responsible Party: Scott Visovatti, MD, Assistant Professor, University of Michigan Identifier: NCT01959815     History of Changes
Other Study ID Numbers: HUM00074818
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

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