Eisenmenger Quality Enhancement Research Initiative

NCT01623492 | Completed

• 1 other identifier: AC-052-435
• Study Type: observational
• Target: 193
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Eisenmenger

Outcome Measures

Primary Outcomes (1)

• Characterization of the clinical course of patients with Eisenmenger Syndrome

  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.

  up to 3 years

Secondary Outcomes (3)

• Characterization of the demographics of patients with Eisenmenger Syndrome

  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.

  baseline (visit 1) thru end of study (3 years)

• Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications.

  baseline (visit 1) thru end of study (3 years)

Study Arms (1)

diagnosis of Eisenmenger Syndrome

subjects with diagnosis of Eisenmenger Syndrome

Other: Subjects with diagnosis of Eisenmenger Syndrome

Interventions

Subjects with diagnosis of Eisenmenger Syndrome OTHER

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

Also known as: management of Eisenmenger Syndrome

diagnosis of Eisenmenger Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actelion: lead
• Canadian Heart Research Centre: collaborator

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.

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Eisenmenger Complex

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Landzberg, MD

  Harvard Medical School / Boston Adult Congenital Heart

  STUDY CHAIR

• Gary Palmer, MD, MBA

  Actelion Pharmaceuticals U.S., Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: June 20, 2012
• Study Start: July 1, 2012
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: February 3, 2025

Record last verified: 2025-01