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Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01623492
Recruitment Status : Completed
First Posted : June 20, 2012
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion

Study Description
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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.

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Other: Subjects with diagnosis of Eisenmenger Syndrome

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.
Study Design
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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

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Groups and Cohorts
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Group/Cohort Intervention/treatment
diagnosis of Eisenmenger Syndrome
subjects with diagnosis of Eisenmenger Syndrome
 Other: Subjects 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
Other Name: management of Eisenmenger Syndrome


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  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) ]

Biospecimen Retention:   Samples Without DNA
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.

Eligibility Criteria
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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
Study Population
200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Actelion
Canadian Heart Research Centre
Investigators
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Study Chair: Michael Landzberg, MD Harvard Medical School / Boston Adult Congenital Heart
Study Director: Gary Palmer, MD, MBA Actelion Pharmaceuticals U.S., Inc.
More Information
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Additional Information:

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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
Keywords provided by Actelion:
Eisenmenger
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Hypertension
Eisenmenger Complex
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
 Lung Diseases
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities