Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients

NCT04212143 | Active Not Recruiting

• 1 other identifier: Pro00013491
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

An observational cohort study will be conducted to non-invasively investigate central blood pressure and pulse wave velocity in children with kidney disease and controls. Using an oscillometric monitor, the investigators aim to non-invasively obtain the central blood pressure and pulse wave velocity (PWV), or arterial stiffness, of children with kidney disease. The investigators will also enroll age- and race-matched healthy controls and measure the same parameters for comparison. In addition, the investigators will measure PWV by standard arterial tonometry method in a subset of patients.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Oscillometric central blood pressure

  Central blood pressure as measured by oscillometric blood pressure device

  cross-sectional measurement performed in patients who are between 6 months to 10 years post-transplant

• Oscillometric pulse wave velocity

  Pulse wave velocity as measured by oscillometric blood pressure device

  cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant

Secondary Outcomes (3)

• Body mass index (BMI) in kg/m2

  cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant

• Waist circumference (cm)

  cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant

• Mid arm circumference (cm)

  cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant

Study Arms (2)

children with kidney disease

Kidney transplant recipients age 3 to 21 years

Other: there is no intervention

healthy control

Healthy children age 3 to 21 years

Other: there is no intervention

Interventions

there is no intervention OTHER

There is no intervention in this study. It is observational only.

children with kidney disease; healthy control

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

pediatric kidney transplant recipients and healthy controls

You may qualify if:

• kidney transplant recipients who are at least 6 months post-transplant
• healthy children matched for age sex and race

You may not qualify if:

• age less than 3 years

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Medical Cetner

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian IV

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 26, 2019
• Study Start: July 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)