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Adult Congenital Heart Disease Registry (QuERI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Actelion
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01659411
First received: July 12, 2012
Last updated: January 6, 2014
Last verified: January 2014

July 12, 2012
January 6, 2014
December 2011
December 2016   (final data collection date for primary outcome measure)
To characterize the clinical course in a cohort of adult patients with repaired CHD at risk for developing PAH [ Time Frame: screening (visit 1) through end of study (3 years) ] [ Designated as safety issue: No ]
outcome measure: clinical outcomes: Assessment of function status, medications, and laboratory results, as well as an evaluation of medical history, physical examination, ECG, and echocardiography, in adult congenital heart disease patients at risk for pulmonary hypertension.
Same as current
Complete list of historical versions of study NCT01659411 on ClinicalTrials.gov Archive Site
To characterize the clinical outcomes in a cohort of adult patients with repaired CHD at risk for developing PAH [ Time Frame: screening (visit 1) through end of study (3 years) ] [ Designated as safety issue: No ]
outcome measure: clinical rate: To assess the rate of newly diagnosed pulmonary arterial hypertension in a cohort of adults with repaired congenital heart disease at risk for pulmonary arterial hypertension. To also compare clinical outcomes in patients who do and do not meet prespecified echocardiography criteria for suspected pulmonary arterial hypertension.
To characterize the clinical outcomes in a cohort of adult patients with repaired CHD at risk for developing PAH [ Time Frame: screening (visit 1) through end of study (3 years) ] [ Designated as safety issue: No ]
outcome measure: clinical rate: To assess the rate of newly diagnosed pulmonary arterial hypertension in a cohort of adults with repaired congenital heart desease at risk for pulmonary arterial hypertension. To also compare clinical outcomes in patients who do and do not meet prespecified echocardiography criteria for suspected pulmonary arterial hypertension.
Not Provided
Not Provided
 
Adult Congenital Heart Disease Registry (QuERI)
Adult Congenital Heart Disease Quality Enhancement Research Initiative

Multi-center, observational, U.S.-based longitudinal program. Data will be collected prospectively for 3 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 from adult patients enrolled with a history of repaired Congenital Heart Disease (CHD).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

adult CHD patients meeting inclusion and exclusion criteria may be enrolled

  • Pulmonary Arterial Hypertension
  • Congenital Heart Disease
Other: observational
yearly clinical visits
Other Name: observational
Adult CHD Patients
observational
Intervention: Other: observational
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
June 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male and female adults (≥ 18 years of age)
  2. Patients with documented history (at least one year) of an isolated, repaired congenital heart defect such as ASD, VSD, PDA, AVC (AVSD)
  3. History of a large defect prior to closure as evidenced by any one of the following:

    • Size of: ASD > 2 cm; VSD > 1 cm; PDA > 0.6 cm
    • Shunt 2:1 or greater
    • Pre-operative PH (PAS > 40 mmHg) or documented shunt- related heart failure (radiographic evidence)
    • Pre-operative atrial fibrillation or flutter
  4. High risk features (any one the following):

    • Age > 40 years
    • Later surgical repair:

1. ≥ 2 years of age for PDA or VSD 2. ≥ 1 year of age for AVC 3. ≥ 10 years of age for ASD

  • sinus venosus defect
  • primum defect
  • WHO functional class > 1
  • atrial fibrillation or flutter 5. Echocardiographic evidence of high risk features. Any one of the following:
  • Degree of TR that is mild or greater
  • Right ventricular (RV) systolic dysfunction
  • Evidence of RV dilatation: Any one of the following:

    1. Evidence of RV dilation by general, qualitative assessment
    2. RV end diastolic diameter > 3.2 cm on apical 4 chamber view at the tips of the tricuspid valve
    3. RV to LV ratio at end-diastole > 0.6 (RV and LV end diastolic dimensions measured from apical 4 chamber view, 1 cm apical of the respective valve annuli)
  • Any abnormality in the motion of the inter-ventricular septum 6. Ability and desire to execute the consent for follow up

Exclusion Criteria:

  1. 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
  2. Diagnosis of PAH (defined as RHC demonstrating mPAP ≥ 25 mm Hg and PCWP ≤ 15 and PVR > 3 WU or PVR (indexed) > 4 WU or treatment with PAH specific therapy) after surgical repair and prior to visit 1.
  3. Prior inclusion in this registry.
Both
18 Years and older
No
Contact: Anatoly Langer, MD 416-999-6264 langera@chrc.net
United States
 
NCT01659411
AC-052-433, CHRC2011-ACHD001
No
Actelion
Actelion
Canadian Heart Research Centre
Study Chair: Michael J Landzberg, MD Boston Adult Congenital Heart Service/PH Service
Actelion
January 2014

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