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Adult Congenital Heart Disease Registry (QuERI)

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ClinicalTrials.gov Identifier: NCT01659411
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Other: Observational

Detailed Description:
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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 217 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Adult Congenital Heart Disease Quality Enhancement Research Initiative
Actual Study Start Date : December 1, 2011
Actual Primary Completion Date : May 16, 2018
Actual Study Completion Date : May 16, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Adult CHD Patients
observational
 Other: Observational
Yearly clinical visits


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult CHD patients meeting inclusion and exclusion criteria may be enrolled
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659411


Locations
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Sponsors and Collaborators
Actelion
Canadian Heart Research Centre
Investigators
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Study Chair: Michael Landzberg, MD Harvard Medical School / Boston Adult Congenital Heart
More Information
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Additional Information:

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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01659411    
Other Study ID Numbers: AC-052-433
CHRC2011-ACHD001 ( Other Identifier: Canadian Identifier )
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Actelion:
Congenital Heart Disease
Pulmonary Arterial Hypertension
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Hypertension
Heart Diseases
Heart Defects, Congenital
Vascular Diseases
Cardiovascular Diseases
 Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities