End Stage Renal DiseaseNCT04212143
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
An observational study of End Stage Renal Disease, run by Children's National Research Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- End Stage Renal Disease
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- Child, Adult
Study population: pediatric kidney transplant recipients and healthy controls
Who may be able to join
- kidney transplant recipients who are at least 6 months post-transplant
- healthy children matched for age sex and race
Who cannot join
- age less than 3 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Cetner
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- End Stage Renal Disease
- Being tested
- there is no intervention
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no interventionOther
There is no intervention in this study. It is observational only.
| Study group | Role | What they receive |
|---|---|---|
| children with kidney disease | Kidney transplant recipients age 3 to 21 years Receives: Other: there is no intervention | |
| healthy control | Healthy children age 3 to 21 years Receives: Other: there is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oscillometric central blood pressure
Central blood pressure as measured by oscillometric blood pressure device
Measured: 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
Measured: cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant
Secondary outcomes (3)
Body mass index (BMI) in kg/m2
weight measured in kg and height measured in cm will be combined to determine BMI (kg/m2)
Measured: 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
Measured: 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
Measured: cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Jul 2021
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Sgambat, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212143
- Sponsor's protocol ID
- Pro00013491
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2019
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No