Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients

Central Blood Pressure and Pulse Wave Velocity in Children With and Without Kidney Transplants

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.

Study Overview

• Status: Recruiting
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: there is no intervention

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Kristen Sgambat, PhD; Phone Number: 202-476-5058; Email: ksgambat@childrensnational.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Children's National Medical Cetner
      • Contact: Asha Moudgil, MD; Email: amoudgil@cnmc.org
      • Contact: Kristen Sgambat
      • Principal Investigator: Asha Moudgil, MD
      • Sub-Investigator: Kristen Sgambat, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

pediatric kidney transplant recipients and healthy controls

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
children with kidney disease; Kidney transplant recipients age 3 to 21 years	Other: there is no intervention; There is no intervention in this study. It is observational only.
healthy control; Healthy children age 3 to 21 years	Other: there is no intervention; There is no intervention in this study. It is observational only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's National Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: Pro00013491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No