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Prognosis and Integrative Assessment of Aortic Coarctation Patients in China

Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04011956
Enrollment
300
Registered
2019-07-09
Start date
2019-03-01
Completion date
2023-12-31
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coarctation of Aorta

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.

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.

Interventions

None listed

Sponsors

Beijing Anzhen Hospital
CollaboratorOTHER
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
CollaboratorOTHER
Capital Institute of Pediatrics, China
CollaboratorOTHER
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in left ventricular massPrior 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.
Hypertensionone month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohortBoth resting blood pressure and exercise-related blood pressure will be assessed for patients above 5 years old during the follow-up visit.

Secondary

MeasureTime frameDescription
Left ventricular systolic heart function of longitudinal myocardiumone month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohortLeft ventricular systolic heart function of longitudinal myocardium assessed by echocardiography (M mode Doppler).
Exercise toleranceone month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohortSix 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.
Biomarkers of vascular inflammationPrior 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.
Biomarkers of left ventricle remodelingFor 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 treatmentBiomarkers of left ventricle remodeling (ST2)
Left ventricular systolic functionone month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohortLeft ventricular systolic function assessed by echocardiography
Biomarkers of hypertension phenotype related to aortic coarctationone month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohortBiomarkers of hypertension phenotype related to aortic coarctation
Recoarctationone month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohortRecoarctation assessed by echocardiography or computed tomography angiography.
All-cause death20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohortThe data is collected during follow-up visit at follow-up time point.
Biomarkers of left heart functionPrior 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.
Left ventricular diastolic functionone month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohortLeft ventricular diastolic function assessed by echocardiography (TDI)

Countries

China

Contacts

Primary ContactYuan WANG, PhD
wangyuan980510@163.com86-010-64456169
Backup ContactYan GU, PhD
echoguyan@163.com86-010-64456874

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026