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

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arizona

Tucson, Arizona, 85724, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

United Therapeutics

Registry information

Official study title

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

Acronym: ISS

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Feb 28, 2014
Registry last updated: Nov 17, 2016

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