Arterial Stiffness in Children and Young People With Hypertension and Chronic Kidney Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-25
SponsorKing's College London

About this trial

Age related stiffening and hardening of the arteries is often a slow process, but some conditions such as chronic kidney disease (CKD), seem to increase the rate at which the arteries stiffen even during childhood. High blood pressure (BP) is well known to lead to arterial stiffening and is often seen in children and young people (CYP) with CKD.

A greater risk of arterial stiffening has been reported in children CYP with CKD compared to healthy CYP and this is thought to be related to the development of high BP, heart problems, and the worsening of kidney damage. The cause is unknown and is unlikely due to age related changes in the arterial wall seen in older adults. Potential mechanisms contributing to arterial stiffening in CYP with CKD include i) abnormalities in the interaction between the heart and the aorta (the large artery pumping blood away from the heart to the rest of the body), overactivity of the sympathetic nervous system (SNS), the body's "stress response", or iii) abnormal metabolism seen in CKD, where there are high levels of phosphate and other waste products circulating in the blood as a result of damage to the kidneys.

In this study, the investigators will use a variety of non invasive experimental methods to determine if arterial stiffening seen in CYP with CKD is due solely to increased BP, or whether the other potential factors listed above also contribute. This may help to eventually identify how to prevent or treat arterial stiffness in CYP with CKD and prevent its adverse impact on kidney and heart health in later life. The investigators will compare findings between those with CKD and an age, sex and BP matched control group. This control group will comprise CYP both with high BP (primary hypertension) and without high BP (healthy participants).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 10-25 years at study entry.

Diagnosis of CKD confirmed on at least two GFR assessments 3-months apart; eGFR will be estimated using routine bedside formulae (modified Schwartz). Participants may include those on dialysis or those with a functioning kidney transplant.

Able to tolerate study investigations including 24-hour ABPM, echocardiogram, vascular assessments and MRI.

Aged 10-25 years at study entry

Disqualifiers

Heart abnormalities or pre-existing cardiac disease including congenital heart disease, previous cardiac surgery or heart failure.

Cardiac dysrhythmia.

Inability to tolerate the required study investigations (out of office BP monitoring, applanation tonometry, cardiac MRI).

Trial population

Children and young adults with chronic kidney disease and age-, sex- and gender-matched healthy controls and those with primary hypertension.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Chronic kidney disease
Group B: Controls

Trial outcomes

Primary outcomes

1

Difference in carotid femoral pulse wave velocity

The difference in carotid femoral pulse wave velocity (m/s) between children and young adults with CKD and age, sex and blood pressure (BP) matched controls.

Time frame
Baseline (single time point)

Secondary outcomes

1

Difference in carotid femoral pulse wave velocity once blood pressure is normalised

The difference in carotid femoral pulse wave velocity (m/s) pre and post anti-hypertensive therapy in children and young adults with CKD.

Time frame
Baseline; Post anti-hypertensive therapy when a clinical blood pressure target of <75th percentile or <130/80mmHg in adults is achieved (anticipated to be 6-9 months post baseline).
2

Difference in sympathetic nerve activity

The difference in markers of sympathetic nerve activity between children and young people with CKD compared to age, sex and BP matched controls as follows: * Plasma catecholamines. * Pulse wave velocity (m/s) difference pre and post device guided slow breathing (DGB). * Pulse wave velocity (m/s) difference pre and post lower limb venous occlusion (LVO)

Time frame
Baseline (single time point)
3

Difference in aortic pulse wave velocity

The difference in aortic pulse wave velocity (m/s) as measured by MRI between children and young adults with CKD and age, sex and BP matched controls.

Time frame
Baseline (single time point)
4

Difference in cardiac output - echocardiography

The difference in cardiac output between CYP with CKD and age, sex and BP matched controls as measured by: Echocardiography

Time frame
Baseline (single time point)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College London

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator