Clinical trial NCT04011956: Prognosis and Integrative Assessment of Aortic Coarctation Patients in China
Official title: Prognosis and Integrative Assessment of Aortic Coarctation Patients in CHINA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coarctation of Aorta
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
name: Capital Institute of Pediatrics, China
First posted: 2019-07-09
Enrollment: 300
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coarctation of the aorta, treated after 2002 in Beijing Anzhen Hospital.

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.

Eligibility 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.

Primary outcomes:
measure: Change in left ventricular mass
timeFrame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
measure: Hypertension
timeFrame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Secondary outcomes:
measure: Left ventricular systolic function
timeFrame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
measure: Left ventricular diastolic function
timeFrame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
measure: Left ventricular systolic heart function of longitudinal myocardium
timeFrame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
measure: Exercise tolerance
timeFrame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
measure: Biomarkers of vascular inflammation
timeFrame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
measure: Biomarkers of left ventricle remodeling
timeFrame: 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
measure: Biomarkers of left heart function
timeFrame: Prior to primary treatment and during follow-up visit(one month to 20 years for retrospective cohort and one year for prospective cohort)
measure: Biomarkers of hypertension phenotype related to aortic coarctation
timeFrame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
measure: Recoarctation
timeFrame: one month to 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
measure: All-cause death
timeFrame: 20 years after primary treatment for retrospective cohort and one year after primary treatment for prospective cohort
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Institute of Heart, Lung and Blood Vessel Diseases
name: Jie DU, PhD
role: PRINCIPAL_INVESTIGATOR
References: