Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)

This study is currently recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2012

Last Updated Date

May 7, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01623492 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Eisenmenger Quality Enhancement Research Initiative

Official Title ^ICMJE

Eisenmenger Quality Enhancement Research Initiative

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

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.

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Eisenmenger

Intervention ^ICMJE

Other: Management

Antibiotic recommendation for SBE prophylaxis and influenza vaccine
Contraception counseling, and recommendations regarding avoidance of pregnancy
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

Study Group/Cohort (s)

diagnosis of Eisenmenger Syndrome

subjects with diagnosis of Eisenmenger Syndrome

Intervention: Other: Management

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

March 2015

Estimated Primary Completion Date

March 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01623492

Other Study ID Numbers ^ICMJE

AC-052-435

Has Data Monitoring Committee

Responsible Party

Actelion

Study Sponsor ^ICMJE

Actelion

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Scott Tsurutani

Actelion Pharmaceuticals U.S., Inc.

Information Provided By

Actelion

Verification Date

May 2013

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

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