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NCT Number: NCT04212143

Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Medical Cetner

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

About this study

The specific aims of the study are as follows:

  • 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.
  • Measure oscillometric central blood pressure and PWV in age and race matched healthy children.
  • Measure PWV by standard arterial tonometry method in a subset of patients, and compare these measurements to the PWV measured using the oscillometric device.
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

There is no intervention

Other

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

Primary outcomes

  1. Oscillometric central blood pressure

    Time frame: 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

  2. Oscillometric pulse wave velocity

    Time frame: 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 outcomes

  1. Body mass index (BMI) in kg/m2

    Time frame: 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)

  2. Waist circumference (cm)

    Time frame: 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

  3. Mid arm circumference (cm)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2019
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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