Adult Congenital Heart Disease Registry (QuERI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01659411
First received: July 12, 2012
Last updated: March 1, 2016
Last verified: March 2016

July 12, 2012
March 1, 2016
December 2011
June 2018   (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).
Approximately 800 male and female adult patients with a history of repaired CHD will be recruited from approximately 100 cardiology practices and will be followed up every twelve months for the period of three years. Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study. Two groups of subjects will be enrolled based on identical exclusion criteria and inclusion criteria, with the exception only of inclusion criteria #3: cohort 1- those demonstrating historic high risk criteria and cohort 2 - those demonstrating current high risk criteria.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
3 Years
Not Provided
Non-Probability Sample
Adult CHD patients meeting inclusion and exclusion criteria may be enrolled
Pulmonary Arterial Hypertension (CHD)
Other: Observational
Yearly clinical visits
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.
 
Active, not recruiting
800
August 2018
June 2018   (final data collection date for primary outcome measure)

Inclusion Criteria: Cohort 1 (historic high risk)

  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:

      i. ≥ 2 years of age for PDA or VSD ii. ≥ 1 year of age for AVC iii. ≥ 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:

      i. Evidence of RV dilation by general, qualitative assessment ii. RV end diastolic diameter > 3.2 cm on apical 4 chamber view at the tips of the tricuspid valve iii. 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

Inclusion Criteria: Cohort 2 (current high risk)

  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. Current (within the last 12 months) evidence of 1 or more of the 7 following criteria:

    • Desaturation on exercise (92% or less)
    • 6 MWD <380 m
    • PFT demonstrating DLC <70% predicted & FEV1>70% predicted
    • ECG demonstrating i) RAD and ii) RVH or RAE
    • Physical findings of edema accompanied by elevated JVP and +HJR
    • CXR evidence of enlarged main and/or hilar pulmonary arterial shadows in association with right ventricular enlargement
    • Elevated biomarks (BNP or NT-proBNP above upper limit of normal)
  4. High risk features (any one of the following:)

    • Age > 40 years
    • Later surgical repair:

      i. ≥ 2 years of age for PDA or VSD ii. ≥ 1 year of age for AVC iii. ≥ 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:

      i. Evidence of RV dilation by general, qualitative assessment ii. RV end diastolic diameter > 3.2 cm on apical 4 chamber view at the tips of the tricuspid valve iii. 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01659411
AC-052-433, CHRC2011-ACHD001
No
Not Provided
Not Provided
Actelion
Actelion
Canadian Heart Research Centre
Study Chair: Michael Landzberg, MD Harvard Medical School / Boston Adult Congenital Heart
Actelion
March 2016

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