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Prognosis and Integrative Assessment of Aortic Coarctation Patients in China

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ClinicalTrials.gov Identifier: NCT04011956
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Beijing Anzhen Hospital
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Capital Institute of Pediatrics, China
Information provided by (Responsible Party):
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Brief Summary:
This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis.

Condition or disease
Coarctation of Aorta

Detailed Description:
The goal is to determine how much the left ventricle remodeling pre-operation and how it changes in the following-up duration after surgery, so does in the blood pressure and heart function. Risk factors associated with complications and prognosis are investigated and analyzed. Identification of novel biomarkers is needed to help predicting the prognosis, such as the left ventricle anti-remodeling, heart function and blood pressure improvement, as well as the exercise tolerance post-operation. The findings of this study will help the investigators developping new tests to monitor affected patients and optimize the operation as well as the follow-up procedure.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Retrospective Cohort of Aortic Coarctation
Patients diagnosed as aortic coarctation and undergone corrected procedures from 2002 to Feb 28th 2019 were recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.
Perspective Cohort of Aortic Coarctation
Patients diagnosed as aortic coarctation and undergone corrected procedures after Mar. 1st 2019 will be recruited in Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.



Primary Outcome Measures :
  1. Change in left ventricular mass [ Time Frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort) ]
    Left ventricular mass will be measured by 2D echocardiography. For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.

  2. Hypertension [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]
    Both resting blood pressure and exercise-related blood pressure will be assessed for patients above 5 years old during the follow-up visit.


Secondary Outcome Measures :
  1. Left ventricular systolic function [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]
    Left ventricular systolic function assessed by echocardiography

  2. Left ventricular diastolic function [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]
    Left ventricular diastolic function assessed by echocardiography (TDI)

  3. Left ventricular systolic heart function of longitudinal myocardium [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]
    Left ventricular systolic heart function of longitudinal myocardium assessed by echocardiography (M mode Doppler).

  4. Exercise tolerance [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]
    Six minutes walking distance will be recorded and analyzed to evaluate the exercise tolerance. Echocardiographic images will be obtained after six minutes walking to assess the reserve function of left ventricle. Blood pressure will also be taken immediately after the Six minutes walking to analyze exercise-induced hypertension.

  5. Biomarkers of vascular inflammation [ Time Frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort) ]
    Biomarkers of inflammation (hs-CRP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.

  6. Biomarkers of left ventricle remodeling [ Time Frame: For the retrospective cohort, follow-up visit of 1 month to 20 years after primary treatment. For the prospective cohort, the data is collected prior to primary treatment and during follow-up visit of one year after primary treatment ]
    Biomarkers of left ventricle remodeling (ST2)

  7. Biomarkers of left heart function [ Time Frame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort) ]
    Biomarkers of left heart function (BNP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.

  8. Biomarkers of hypertension phenotype related to aortic coarctation [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]
    Biomarkers of hypertension phenotype related to aortic coarctation

  9. Recoarctation [ Time Frame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]
    Recoarctation assessed by echocardiography or computed tomography angiography.

  10. All-cause death [ Time Frame: 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort ]
    The data is collected during follow-up visit at follow-up time point.


Biospecimen Retention:   Samples With DNA
If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA. If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coarctation of the aorta, treated after 2002 in Beijing Anzhen Hospital.
Criteria

Inclusion Criteria:

  • Diagnosis of isolated coarctation of the aorta, or accompanied with atrial septal defect(ASD), ventricular septal defect (VSD), patent ductus arteriosus( PDA), patent foramen ovale (PFO);
  • Patients who can cooperation with study procedures.

Exclusion Criteria:

  • Co-morbidities that may independently affect cardiovascular function, including associated complicated congenital heart disease, such as hypoplastic left heart syndrome (HLHS), interruption of aortic arch (IAA), Shone Syndrome, moderate and severe mitral stenosis;
  • History of known vasculopathy, genetic syndromes, diabetes mellitus, hyperlipoidemia or other cardiovascular risk factors.

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): NCT04011956


Contacts
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Contact: Yuan WANG, PhD 86-010-64456169 wangyuan980510@163.com
Contact: Yan GU, PhD 86-010-64456874 echoguyan@163.com

Locations
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China, Beijing
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Yuan WANG, PhD    86-010-64456169    wangyuan980510@163.com   
Contact: Yan GU, PhD    86-010-64456874    echoguyan@163.com   
Sponsors and Collaborators
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Beijing Anzhen Hospital
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
Capital Institute of Pediatrics, China
Investigators
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Principal Investigator: Jie DU, PhD Beijing Institute of Heart, Lung and Blood Vessel Diseases
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Responsible Party: Beijing Institute of Heart, Lung and Blood Vessel Diseases
ClinicalTrials.gov Identifier: NCT04011956    
Other Study ID Numbers: PICC
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities