Novel Screening Strategies for Scleroderma PAH
Verified October 2013 by University of Michigan
Information provided by (Responsible Party):
Scott Visovatti, MD, University of Michigan
First received: October 8, 2013
Last updated: October 9, 2013
Last verified: October 2013
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.
Pulmonary Arterial Hypertension
||Observational Model: Cohort
Time Perspective: Prospective
Primary Outcome Measures:
- Development of pulmonary arterial hypertension [ Time Frame: Two years after enrollment. ] [ Designated as safety issue: No ]
Blood samples will be drawn at rest and during exercise.
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||October 2018 (Final data collection date for primary outcome measure)
Scleroderma and diagnosed PAH
"Low risk" scleroderma
"High risk" scleroderma
|Ages Eligible for Study:
||30 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Volunteers will be recruited from scleroderma clinics, pulmonary hypertension clinics, and (for healthy volunteers) the Ann Arbor area.
- 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).
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
|University of Michigan
|Ann Arbor, Michigan, United States, 48109 |
|Contact: Aileen Patel, BSN 866-963-3587 email@example.com |
|Principal Investigator: Scott Visovatti, MD |
University of Michigan
No publications provided
||Scott Visovatti, MD, Clinical Lecturer, University of Michigan
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 8, 2013
||October 9, 2013
||United States: Data and Safety Monitoring Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Respiratory Tract Diseases
Connective Tissue Diseases