Novel Screening Strategies for Scleroderma PAH

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Connective Tissue Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Scleroderma Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

Development of pulmonary arterial hypertension

Time frame: Two years after enrollment.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Novel Screening Strategies for Scleroderma PAH (Pulmonary Arterial Hypertension)

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2019
First posted: Oct 10, 2013
Registry last updated: Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed