Cardiovascular Comorbidity in Children With Chronic Kidney Disease

NCT ID: NCT03227055

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 155 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-30
• Study Completion Date: 2019-12-31

Brief Summary

This 3-year study will systematically evaluate the prevalence, clinical symptoms, and progression of CV and kidney disease and assess the impact of potential genetic, pharmacological, behavior, and environmental risk factors in a prospective cohort with a sample size of 125 aged 3-18 years children with stage G1-G4 chronic kidney disease (CKD). Measurements of morphological (e.g., LVMI & cIMT) and functional characteristics (e.g., FMD & PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA & urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.

Detailed Description

Taiwan has the highest incidence and prevalence rates of end-stage renal disease all over the world. Chronic kidney disease (CKD) becomes a global public health burden, which can begin in earliest childhood. CKD in childhood differs from that in adults. Congenital anomalies of the kidney and urinary tract (CAKUT) is the leading cause of childhood CKD. Children with CKD due to CAKUT have the highest risk of having a genomic imbalance. Thus, early identification of genotype-phenotype correlations to develop novel therapeutic approaches might reduce the heavy burden of CKD for the future of Taiwan.

Study design:

1. A 3-year prospective cohort study.

2. Sample size: 125 children and adolescents with stage G1-G4 CKD, age 3 to 18 yr, and 30 controls.

4. Measurement: Measurements of morphological (e.g., LVMI & cIMT) and functional characteristics (e.g., FMD & PWV) of the cardiovascular system and 24hr ABPM profile will serve as surrogate end points for CV comorbidity in this study. Possible associations of these end points with multiple molecular (ADMA & urine exosome miRNA), perceived value and behavior (EQ-5D-Y), pharmacological (NHIRD and CGRD), and environmental risk factors (patient and family survey) will be explored.

Conditions

Childhood Chronic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CKD

Children and adolescents with stage G1-G4 CKD, age 3 to 18 yr

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• children and adolescents with stage G1-G4 CKD

Exclusion Criteria

• current pregnancy
• inability to complete major data collection
• kidney transplant
• cancer

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tain, You-Lin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

201601181A3

Identifier Type: -

Identifier Source: org_study_id