Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients

Active, not recruiting

• Conditions: End Stage Renal Disease
• Interventions: Other: there is no intervention

• Registration Number: NCT04212143
• Lead Sponsor: Children's National Research Institute

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.

Detailed Description

The specific aims of the study are as follows:

1. Using an oscillometric blood pressure 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.

2. Measure oscillometric central blood pressure and PWV in age and race matched healthy children.

3. Measure PWV by standard arterial tonometry method in a subset of patients, and compare these measurements to the PWV measured using the oscillometric device.

4. Measure body composition of patients and controls (Body Mass Index, Waist-to-Height ratio, %body fat, and mid-arm muscle circumference) to see how this relates to central blood pressure and PWV.

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-26
• Study Start: 2021-07-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• age less than 3 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children with kidney disease	there is no intervention	Kidney transplant recipients age 3 to 21 years
healthy control	there is no intervention	Healthy children age 3 to 21 years

Primary Outcome Measures

Name	Time	Method
Oscillometric central blood pressure	cross-sectional measurement performed in patients who are between 6 months to 10 years post-transplant	Central blood pressure as measured by oscillometric blood pressure device
Oscillometric pulse wave velocity	cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant	Pulse wave velocity as measured by oscillometric blood pressure device

Secondary Outcome Measures

Name	Time	Method
Mid arm circumference (cm)	cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant	Mid arm circumference will be measured in cm using a flexible tape measure
Body mass index (BMI) in kg/m2	cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant	weight measured in kg and height measured in cm will be combined to determine BMI (kg/m2)
Waist circumference (cm)	cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant	waist circumference will be measured in cm using a flexible tape measure

Trial Locations

Locations (1)

Children's National Medical Cetner; 🇺🇸 Washington, District of Columbia, United States