Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients

NCT ID: NCT04212143

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2026-07-01

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.

Conditions

End Stage Renal Disease

Study Design

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

Study Groups

children with kidney disease

Kidney transplant recipients age 3 to 21 years

there is no intervention

Intervention Type: OTHER

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

healthy control

Healthy children age 3 to 21 years

there is no intervention

Intervention Type: OTHER

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

Interventions

there is no intervention

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Kristen Sgambat

Clinical Dietitian IV

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's National Medical Cetner

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

Countries

United States

Other Identifiers

Pro00013491

Identifier Type: -

Identifier Source: org_study_id