Prognosis and Integrative Assessment of Aortic Coarctation Patients in China

Coarctation of Aorta Clinical Trial

Official title:

Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04011956
• Other study ID #: PICC
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2020
• Source: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Contact: Yuan WANG, PhD
• Phone: 86-010-64456169
• Email: wangyuan980510[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of Aorta

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (4)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular mass	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.	Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Primary	Hypertension	Both resting blood pressure and exercise-related blood pressure will be assessed for patients above 5 years old during the follow-up visit.	one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Secondary	Left ventricular systolic function	Left ventricular systolic function assessed by echocardiography	one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Secondary	Left ventricular diastolic function	Left ventricular diastolic function assessed by echocardiography (TDI)	one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Secondary	Left ventricular systolic heart function of longitudinal myocardium	Left ventricular systolic heart function of longitudinal myocardium assessed by echocardiography (M mode Doppler).	one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Secondary	Exercise tolerance	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.	one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Secondary	Biomarkers of vascular inflammation	Biomarkers of inflammation (hs-CRP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.	Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Secondary	Biomarkers of left ventricle remodeling	Biomarkers of left ventricle remodeling (ST2)	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
Secondary	Biomarkers of left heart function	Biomarkers of left heart function (BNP). For the retrospective cohort, the data is collected from the cases' medical record, and during follow-up visit.	Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
Secondary	Biomarkers of hypertension phenotype related to aortic coarctation	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
Secondary	Recoarctation	Recoarctation assessed by echocardiography or computed tomography angiography.	one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Secondary	All-cause death	The data is collected during follow-up visit at follow-up time point.	20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort