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CompletedNCT01623492ES-QuERIUpdated Feb 3, 2025

Eisenmenger Quality Enhancement Research Initiative

An observational study in Pulmonary Arterial Hypertension, sponsored by Actelion. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Actelion (part of Johnson & Johnson) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
193
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • Eisenmenger
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In context

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's enrollment of 193 is above the median of 104 across 181 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Actelion is the lead sponsor of 143 studies on the registry; 1 is open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 25 (89%) have results posted.

First submitted before Actelion became part of Johnson & Johnson.

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

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Who can participate

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

Study population

200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.

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

  • 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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
193 participants (actual)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • diagnosis of Eisenmenger Syndrome

    subjects with diagnosis of Eisenmenger Syndrome

    Other: Subjects with diagnosis of Eisenmenger Syndrome

Interventions

  • OtherSubjects with diagnosis of Eisenmenger Syndrome

    1. Antibiotic recommendation for SBE prophylaxis and influenza vaccine 2. Contraception counseling, and recommendations regarding avoidance of pregnancy 3. Documentation and prescription of the specific medications: 1. Oxygen 2. Diuretic 3. ASA, Anticoagulant 4. CCB, BB, ACEI, ARB 5. Iron Supplementation 6. Allopurinol 7. PAH specific therapy

    Also known as: management of Eisenmenger Syndrome

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What researchers measure

Primary outcomes

  1. Characterization of the clinical course of patients with Eisenmenger Syndrome

    The management of Eisenmenger Syndrome patients over the three year registry period will be compared with established national guidelines. In addition, The Minnesota Living with Heart Failure questionnaire (MLHFQ) will be collected.

    Time frame: up to 3 years

Secondary outcomes

  1. Characterization of the demographics of patients with Eisenmenger Syndrome

    Time frame: baseline (visit 1) thru end of study (3 years)

  2. Identification of clinical predictors of short-term and long-term outcomes of patients with Eisenmenger Syndrome.

    Time frame: baseline (visit 1) thru end of study (3 years)

  3. Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications.

    Time frame: baseline (visit 1) thru end of study (3 years)

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01623492
Lead sponsor
Actelion
Collaborators
Canadian Heart Research Centre
Responsible party
Sponsor
First posted
Jun 20, 2012
Start date
Jul 1, 2012
Primary completion
Apr 17, 2018
Completion
Apr 17, 2018
Last update
Feb 3, 2025

Study contacts

Michael Landzberg, MD
study chair · Harvard Medical School / Boston Adult Congenital Heart
Gary Palmer, MD, MBA
study director · Actelion Pharmaceuticals U.S., Inc.

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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