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Study Of Right Ventricular Performance In PAH Patients Treated With Rapid Dose Treprostinil (Remodulin)

NCT ID: NCT02074449

Last Updated: 2016-11-17

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

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

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Patients with pulmonary arterial hypertension (PAH) are at much higher risk of death if the RV (right ventricle) is weak. The purpose of this study is to get a better understanding of the factors that determine RV adaptation and how the RV compensates on therapy. The investigator is also interested in how Remodulin (treprostinil) infused over a short period (approximately 48-72 hours) affects the patient's quality of life, medical care, and personal health behaviors.

Treprostinil, also known as Remodulin, has been approved by the US Food and Drug Administration for use in the treatment of PAH. The investigator has been treating patients with Remodulin by rapid infusion (over 48 hours) for over 6 years. The investigator would like to establish this practice as safe and effective for the benefit of other centers that treat PAH.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Keywords

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Pulmonary Arterial Hypertension Right Ventricular Performance Treprostinil Remodulin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with clinically suspected World Health Organization (WHO) group I PAH
* Patients with New York Heart Association/WHO functional class II-IV
* Patients with mean pulmonary artery pressure \>25 mmHg, pulmonary capillary wedge pressure \</=15 mmHg, and pulmonary vascular resistance \>3 wood units
* Age \>18 and \<80
* No evidence of active ischemic heart disease

Exclusion Criteria

* Left ventricular ejection fraction \<50%
* Patients with significant restrictive lung disease (FVC \<60% predicted) and/or significant obstructive lung disease (FEV1 \<55% predicted) within 1 year of enrollment if pulmonary function testing is available
* Patients with significant, investigator-determined parenchymal lung disease on chest x-ray or CT of the chest
* History of pulmonary embolism within the last three months or chronic pulmonary embolism
* Poorly interpretable grey scale echocardiographic images
* Contraindications to right heart catheterization
* Moderate-severe aortic and mitral valve abnormality
* Active or previous use of pulmonary vasoactive medication within the previous 12 weeks
* Renal failure with serum creatinine clearance \<30 ml/hr
* High-probability ventilation-perfusion scan
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United Therapeutics

INDUSTRY

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franz Rischard, D.O.

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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ISS

Identifier Type: -

Identifier Source: org_study_id