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
  Purpose

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
Pulmonary Arterial Hypertension
Scleroderma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Development of pulmonary arterial hypertension [ Time Frame: Two years after enrollment. ] [ Designated as safety issue: No ]

Biospecimen Description:

Blood samples will be drawn at rest and during exercise.


Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Scleroderma and diagnosed PAH
"Low risk" scleroderma
Healthy volunteers
"High risk" scleroderma

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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).
  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: NCT01959815

Contacts
Contact: Aileen Patel, BSN 866-963-3587 cvc-ph-research@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Aileen Patel, BSN    866-963-3587    cvc-ph-research@med.umich.edu   
Principal Investigator: Scott Visovatti, MD         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Scott Visovatti, MD, Clinical Lecturer, University of Michigan
ClinicalTrials.gov Identifier: NCT01959815     History of Changes
Other Study ID Numbers: HUM00074818
Study First Received: October 8, 2013
Last Updated: October 9, 2013
Health Authority: United States: Data and Safety Monitoring Board

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

ClinicalTrials.gov processed this record on August 28, 2014