Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)
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ClinicalTrials.gov Identifier: NCT01623492 |
Recruitment Status :
Completed
First Posted : June 20, 2012
Last Update Posted : January 23, 2019
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Condition or disease | Intervention/treatment |
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Pulmonary Arterial Hypertension | Other: Subjects with diagnosis of Eisenmenger Syndrome |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 193 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Years |
Official Title: | Eisenmenger Quality Enhancement Research Initiative |
Actual Study Start Date : | July 1, 2012 |
Actual Primary Completion Date : | April 17, 2018 |
Actual Study Completion Date : | April 17, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
diagnosis of Eisenmenger Syndrome
subjects with diagnosis of Eisenmenger Syndrome
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Other: Subjects with diagnosis of Eisenmenger Syndrome
Other Name: management of Eisenmenger Syndrome |
- Characterization of the clinical course of patients with Eisenmenger Syndrome [ Time Frame: up to 3 years ]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.
- Characterization of the demographics of patients with Eisenmenger Syndrome [ Time Frame: baseline (visit 1) thru end of study (3 years) ]
- 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) ]
- 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) ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623492

Study Chair: | Michael Landzberg, MD | Harvard Medical School / Boston Adult Congenital Heart | |
Study Director: | Gary Palmer, MD, MBA | Actelion Pharmaceuticals U.S., Inc. |
Responsible Party: | Actelion |
ClinicalTrials.gov Identifier: | NCT01623492 |
Other Study ID Numbers: |
AC-052-435 |
First Posted: | June 20, 2012 Key Record Dates |
Last Update Posted: | January 23, 2019 |
Last Verified: | January 2019 |
Eisenmenger |
Hypertension Eisenmenger Complex Vascular Diseases Cardiovascular Diseases |
Heart Defects, Congenital Cardiovascular Abnormalities Heart Diseases Congenital Abnormalities |