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Completed

NCT Number: NCT01623492

Eisenmenger Quality Enhancement Research Initiative

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eisenmenger Complex Heart Defects, Congenital Heart Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subjects with diagnosis of Eisenmenger Syndrome

Other
  • Antibiotic recommendation for SBE prophylaxis and influenza vaccine
  • Contraception counseling, and recommendations regarding avoidance of pregnancy
  • Documentation and prescription of the specific medications:
  • Oxygen
  • Diuretic
  • ASA, Anticoagulant
  • CCB, BB, ACEI, ARB
  • Iron Supplementation
  • Allopurinol
  • PAH specific therapy

Other names: management of Eisenmenger Syndrome

Primary outcomes

  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 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)

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Collaborators

  • Canadian Heart Research Centre

Registry information

Acronym: ES-QuERI

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2012
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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