Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212143
• Other study ID #: Pro00013491
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: August 2023
• Source: Children's National Research Institute
• Contact: Kristen Sgambat, PhD
• Phone: 202-476-5058
• Email: ksgambat[@]childrensnational.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2024
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• there is no intervention
There is no intervention in this study. It is observational only.

Locations

Country	Name	City	State
United States	Children's National Medical Cetner	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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