Clinical trial NCT04212143: Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
Official title: Central Blood Pressure and Pulse Wave Velocity in Children With and Without Kidney Transplants
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: End Stage Renal Disease
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric kidney transplant recipients and healthy controls

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.

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

Primary outcomes:
measure: Oscillometric central blood pressure
timeFrame: cross-sectional measurement performed in patients who are between 6 months to 10 years post-transplant
measure: Oscillometric pulse wave velocity
timeFrame: cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant
Secondary outcomes:
measure: Body mass index (BMI) in kg/m2
timeFrame: cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant
measure: Waist circumference (cm)
timeFrame: cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant
measure: Mid arm circumference (cm)
timeFrame: cross-sectional measurement performed in patients who are anywhere between 6 months to 10 years post-transplant
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Cetner
state: District of Columbia
Study officials:
References: