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

Pulmonary Arterial Hypertension Clinical Trial

— ISS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074449
• Other study ID #: ISS
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2014
• Last updated: November 15, 2016
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of change in RV coupling index on treprostinil between baseline, titration at 48-72 hours, and 3 months.		3 months	No