Prognosis and Integrative Assessment of Aortic Coarctation Patients in China

• Conditions: Coarctation of Aorta

• Registration Number: NCT04011956
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in left ventricular mass	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.
Hypertension	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

Name	Time	Method
Left ventricular systolic function	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
Exercise tolerance	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.
Biomarkers of left ventricle remodeling	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)
Left ventricular diastolic function	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)
Recoarctation	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.
Left ventricular systolic heart function of longitudinal myocardium	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).
Biomarkers of left heart function	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.
Biomarkers of vascular inflammation	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.
All-cause death	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.
Biomarkers of hypertension phenotype related to aortic coarctation	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

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China