Clinical trial NCT01623492: Eisenmenger Quality Enhancement Research Initiative
Official title: Eisenmenger Quality Enhancement Research Initiative
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Eisenmenger
Lead sponsor: Actelion
Sponsor class: INDUSTRY
Collaborators: name: Canadian Heart Research Centre
First posted: 2012-06-20
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Characterization of the clinical course of patients with Eisenmenger Syndrome
timeFrame: up to 3 years
Secondary outcomes:
measure: Characterization of the demographics of patients with Eisenmenger Syndrome
timeFrame: baseline (visit 1) thru end of study (3 years)
measure: Identification of clinical predictors of short-term and long-term outcomes of patients with Eisenmenger Syndrome.
timeFrame: baseline (visit 1) thru end of study (3 years)
measure: Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications.
timeFrame: baseline (visit 1) thru end of study (3 years)
Other outcomes:
Locations:
Study officials:
affiliation: Harvard Medical School / Boston Adult Congenital Heart
name: Michael Landzberg, MD
role: STUDY_CHAIR
affiliation: Actelion Pharmaceuticals U.S., Inc.
name: Gary Palmer, MD, MBA
role: STUDY_DIRECTOR
References: