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

NCT02074449 | Completed

• 1 other identifier: ISS
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension; Right Ventricular Performance; Treprostinil; Remodulin

Outcome Measures

Primary Outcomes (1)

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

  3 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Pulmonary Arterial Hypertension

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• United Therapeutics: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Franz Rischard, D.O.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: December 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 17, 2016

Record last verified: 2014-02

Locations

US (1)