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NCT01959815 Clinical Trial

Novel Screening Strategies for Scleroderma PAH

Pulmonary Arterial Hypertension Clinical Trial

Official title:
Novel Screening Strategies for Scleroderma PAH (Pulmonary Arterial Hypertension)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01959815
Other study ID # HUM00074818
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 26, 2013
Est. completion date November 6, 2019

Study information
Verified date November 2021
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date November 6, 2019
Est. primary completion date November 6, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development of pulmonary arterial hypertension Two years after enrollment.
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