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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Eisenmenger Quality Enhancement Research Initiative (QuERI) is a multi-center, observational, US-based longitudinal program, with enrollment of consecutive Eisenmenger patients who meet enrollment. Patient data will be collected prospectively for three years. Individual physician feedback will be provided on data collected with the purpose of improving the management of patients - quality enhancement research initiative (QuERI) process.

Details

Approximately 200 male and female adult patients with a history of Eisenmenger will be recruited from approximately 50 cardiology practices over a period of 18 months and will be followed up every six months for the period of three years. Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study. Participating sites will be asked to maintain a screening log to identify which inclusion or exclusion criteria was not met thus excluding them from the study.

Keywords

Pulmonary Arterial Hypertension Eisenmenger Hypertension Familial Primary Pulmonary Hypertension Eisenmenger Complex

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male and female patients
  • Diagnosis of Eisenmenger syndrome based on right heart catheterization data
  • Right to Left intra-cardiac shunting
  • PAH
  • Need for comprehensive management according to guidelines and peer-reviewed evidence
  • Ability and desire to execute the consent for follow up

You CAN'T join if...

  • Poor mental function, drug, or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
  • Prior inclusion in this program

Locations

  • University of California, San Francisco
    San Francisco, California, 94143-0214, United States
  • Centre for Adult Congenital Heart Disease at California Pacific
    San Francisco, California, 94115, United States
  • Berkeley Cardiovascular Medical Group
    Oakland, California, 94609, United States
  • Lucile Packard Children's Hospital
    Palo Alto, California, 94303, United States
  • University of Southern California Adult Congenital Heart Disease Care Program
    Los Angeles, California, 90033, United States
  • Harbor - UCLA Medical Center - Adult Congenital Heart Disease Program - Division of Cardiology
    Torrance, California, 90502, United States
  • Ahmanson / UCLA Adult Congenital Heart Disease Center
    Los Angeles, California, 90095, United States
  • Children's Heart Center Nevada
    Las Vegas, Nevada, 89109, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Actelion
ID
NCT01623492
Study Type
Observational [Patient Registry]
Last Updated
April 21, 2017