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

November 15, 2016 updated by: University of Arizona

Comprehensive Characterization Of Right Ventricular Performance And Afterload In Patients With Pulmonary Arterial Hypertension Undergoing Initiation And Rapid Dose Escalation Of Treprostinil

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.

Study Overview

Status

Completed

Conditions

Pulmonary Arterial Hypertension

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Tucson, Arizona, United States, 85724
    - University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Pulmonary Arterial Hypertension

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of change in RV coupling index on treprostinil between baseline, titration at 48-72 hours, and 3 months. Time Frame: 3 months	3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

United Therapeutics

Investigators

Principal Investigator: Franz Rischard, D.O., University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria