Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01623492
First received: May 9, 2012
Last updated: May 7, 2013
Last verified: May 2013

May 9, 2012
May 7, 2013
July 2012
March 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01623492 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Eisenmenger Quality Enhancement Research Initiative
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

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

Eisenmenger
Other: Management
  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
diagnosis of Eisenmenger Syndrome
subjects with diagnosis of Eisenmenger Syndrome
Intervention: Other: Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
United States
 
NCT01623492
AC-052-435
No
Actelion
Actelion
Not Provided
Study Chair: Scott Tsurutani Actelion Pharmaceuticals U.S., Inc.
Actelion
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP