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Novel Screening Strategies for Scleroderma PAH

NCT ID: NCT01959815

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-26

Study Completion Date

2019-11-06

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension Scleroderma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Scleroderma and diagnosed PAH

No interventions assigned to this group

"Low risk" scleroderma

No interventions assigned to this group

Healthy volunteers

No interventions assigned to this group

"High risk" scleroderma

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Scott Visovatti, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott H Visovatti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00074818

Identifier Type: -

Identifier Source: org_study_id