Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Actelion
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01623492
First received: May 9, 2012
Last updated: April 20, 2015
Last verified: April 2015
  Purpose

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 Intervention
Eisenmenger
Other: subjects with diagnosis of Eisenmenger Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eisenmenger Quality Enhancement Research Initiative

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Characterization of the clinical course of patients with Eisenmenger Syndrome [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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:
  • Characterization of the demographics of patients with Eisenmenger Syndrome [ Time Frame: baseline (visit 1) thru end of study (3 years) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623492

Contacts
Contact: Anatoly Langer, MD 416-999-6264 langera@chrc.net

  Show 51 Study Locations
Sponsors and Collaborators
Actelion
Canadian Heart Research Centre
Investigators
Study Director: Alain Romero, PharmD Actelion Pharmaceuticals U.S., Inc.
Study Chair: Michael Landzberg, MD Harvard Medical School / Boston Adult Congenital Heart
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01623492     History of Changes
Other Study ID Numbers: AC-052-435
Study First Received: May 9, 2012
Last Updated: April 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Actelion:
Eisenmenger

Additional relevant MeSH terms:
Eisenmenger Complex
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases

ClinicalTrials.gov processed this record on June 01, 2015