Eisenmenger Quality Enhancement Research Initiative

Pulmonary Arterial Hypertension Clinical Trial

— ES-QuERI  

Official title:

Eisenmenger Quality Enhancement Research Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623492
• Other study ID #: AC-052-435
• Status: Completed
• Start date: July 1, 2012
• Est. completion date: April 17, 2018

Study information

• Verified date: January 2019
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: April 17, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eisenmenger Complex
• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Other:
• Subjects with diagnosis of Eisenmenger Syndrome
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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Asheville Cardiology Associates	Asheville	North Carolina
United States	University of Colorado Hospital	Aurora	Colorado
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Children's Hospital Boston and Brigham and Women's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center - Moses Division;The University Hospital for Albert Einstein College of Medicine	Bronx	New York
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	North Carolina
United States	University of Virginia Health Systems	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	CINCINNATI Children's Hospital Medical Center	Cincinnati	Ohio
United States	UC Health/University of Cincinnati	Cincinnati	Ohio
United States	The Cleveland Clinic Adult Congenital Heart Disease Center	Cleveland	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	The Research Institute at Nationwide Children's Hospital	Columbus	Ohio
United States	Bassett Healthcare Network - Bassett Medical Center	Cooperstown	New York
United States	Duke University Medical Center	Durham	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	The Pennsylvania State University College of Medicine and The Pennsylvania State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Texas Children's Hospital/Baylor College of Medicine	Houston	Texas
United States	Mid-America Heart Institute / Saint Luke's Hospital / Saint Luke's Cardiovascular Consultants	Kansas City	Missouri
United States	The University of Kansas Hospital	Kansas City	Kansas
United States	Children's Heart Center Nevada	Las Vegas	Nevada
United States	The University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Ahmanson / UCLA Adult Congenital Heart Disease Center	Los Angeles	California
United States	University of Southern California Adult Congenital Heart Disease Care Program	Los Angeles	California
United States	University of Louisville, Pediatric Cardiology	Louisville	Kentucky
United States	The Cardiovascular Group Centra	Lynchburg	Virginia
United States	Methodist Lebonheur Healthcare, UT Lebonheur Pediatric Specialists	Memphis	Tennessee
United States	Children's Hospital of Wisconsin, Medical College of Wisconsin Adult Congenital Heart Disease Program	Milwaukee	Wisconsin
United States	University of Minnesota Physicians Heart Fairview	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale School of Medicine - Adult Congenital Heart Disease Program	New Haven	Connecticut
United States	Cohen's Children's Medical Center of New York - Adult Congenital Heart Disease Program	New Hyde Park	New York
United States	Columbia University Pulmonary Hypertension Center	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	Children's Specialty Group PLLC, Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	Berkeley Cardiovascular Medical Group	Oakland	California
United States	Lucile Packard Children's Hospital	Palo Alto	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon
United States	Pediatric Cardiology Associates	Portland	Maine
United States	Barnes-Jewish Hospital/St. Louis Children's Hospital / Washington University School of Medicine	Saint Louis	Missouri
United States	Centre for Adult Congenital Heart Disease at California Pacific	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	Providence Sacred Heart Medical Center and Children's Hospital	Spokane	Washington
United States	Harbor - UCLA Medical Center - Adult Congenital Heart Disease Program - Division of Cardiology	Torrance	California
United States	Children's National Medical Center and Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Actelion	Canadian Heart Research Centre

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Characterization of the demographics of patients with Eisenmenger Syndrome		baseline (visit 1) thru end of study (3 years)
Secondary	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)
Secondary	Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications.		baseline (visit 1) thru end of study (3 years)