Study Of Right Ventricular Performance In PAH Patients Tr... | NCT02074449

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

NCT02074449

Sponsor

University of Arizona

Status

Completed

Last Update Posted

Nov 17, 2016Estimated

Enrollment

15Actual

Phase

Not provided

Conditions

Pulmonary Arterial Hypertension

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Feb 26, 2014

First Submission Date that Met QC Criteria

Feb 26, 2014

First Posted Date

Feb 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2016

Last Update Posted Date

Nov 17, 2016Estimated

Name	Class
United Therapeutics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Pulmonary Arterial Hypertension

Sampling Method

Non-Probability Sample

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases