Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-28 @ 8:46 PM
Study NCT ID:
NCT01623492
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2012-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eisenmenger Quality Enhancement Research Initiative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D004541', 'term': 'Eisenmenger Complex'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples will be collected at Baseline and at each of the annual visits. In addition, urine sampling will be performed at Baseline. An analysis of biomarkers will be performed at a hospital core laboratory.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2012-05-09', 'studyFirstSubmitQcDate': '2012-06-19', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of the clinical course of patients with Eisenmenger Syndrome', 'timeFrame': 'up to 3 years', 'description': '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.'}], 'secondaryOutcomes': [{'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)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Eisenmenger'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients\n* Diagnosis of Eisenmenger syndrome based on right heart catheterization data\n* Right to Left intra-cardiac shunting\n* PAH\n* Need for comprehensive management according to guidelines and peer-reviewed evidence\n* Ability and desire to execute the consent for follow up\n\nExclusion Criteria:\n\n* 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\n* Prior inclusion in this program'}, 'identificationModule': {'nctId': 'NCT01623492', 'acronym': 'ES-QuERI', 'briefTitle': 'Eisenmenger Quality Enhancement Research Initiative', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actelion'}, 'officialTitle': 'Eisenmenger Quality Enhancement Research Initiative', 'orgStudyIdInfo': {'id': 'AC-052-435'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diagnosis of Eisenmenger Syndrome', 'description': 'subjects with diagnosis of Eisenmenger Syndrome', 'interventionNames': ['Other: Subjects with diagnosis of Eisenmenger Syndrome']}], 'interventions': [{'name': 'Subjects with diagnosis of Eisenmenger Syndrome', 'type': 'OTHER', 'otherNames': ['management of Eisenmenger Syndrome'], 'description': '1. Antibiotic recommendation for SBE prophylaxis and influenza vaccine\n2. Contraception counseling, and recommendations regarding avoidance of pregnancy\n3. Documentation and prescription of the specific medications:\n\n 1. Oxygen\n 2. Diuretic\n 3. ASA, Anticoagulant\n 4. CCB, BB, ACEI, ARB\n 5. Iron Supplementation\n 6. Allopurinol\n 7. PAH specific therapy', 'armGroupLabels': ['diagnosis of Eisenmenger Syndrome']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael Landzberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard Medical School / Boston Adult Congenital Heart'}, {'name': 'Gary Palmer, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Actelion Pharmaceuticals U.S., Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actelion', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Canadian Heart Research Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}