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CompletedNCT02074449ISSUpdated Nov 17, 2016

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

An observational study in Pulmonary Arterial Hypertension, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-17.

Sponsored by University of Arizona · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • Pulmonary Arterial Hypertension
  • Right Ventricular Performance
  • Treprostinil
  • Remodulin
03

In context

Pulmonary Arterial Hypertension

773 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 201 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

University of Arizona is the lead sponsor of 475 studies on the registry; 87 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.

Browse University of Arizona studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Pulmonary Arterial Hypertension

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Time frame: 3 months

07

Study locations

1 site
  • University of Arizona
    Tucson, Arizona 85724, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2012, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2014
First posted
Feb 28, 2014
Start
Dec 2012
Primary completionActual
Dec 2015
CompletionActual
Dec 2015
Last update
Nov 17, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02074449
Lead sponsor
University of Arizona
Collaborators
United Therapeutics
Responsible party
Sponsor
First posted
Feb 28, 2014
Start date
Dec 2012
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Nov 17, 2016

Study contacts

Franz Rischard, D.O.
principal investigator · University of Arizona

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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