Chronic Kidney DiseaseART-KIDSNCT07768865
Arterial Stiffness in Children and Young People With Hypertension and Chronic Kidney Disease
An observational study of Chronic Kidney Disease and Hypertension, run by King's College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2026to 16 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and young adults with chronic kidney disease and age-, sex- and gender-matched healthy controls and those with primary hypertension.
Who may be able to join
- For CKD participants:
- 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.
- For controls:
- Aged 10-25 years at study entry
- Having completed study measurements as part of other research being completed by the research group and having consented to their anonymised data being used in future research within the same research theme.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Evelina London Children's Hospital and Guys and St Thomas' NHS Foundation Trust
London, Greater London, SE1 7EH
benjamin boxer, PhD, +44 20 7188 4770, benjamin.boxer@kcl.ac.uk
Louise Keehn, MSc, +44 20 7188 4770, louise.keehn@kcl.ac.uk
About this study
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).
Read the detailed description
Methods:
Single time point assessment of aortic stiffness of children and young people with CKD; recruitment target of in total 100 participants, of which: 50 pre-dialysis (CKD stage 1-5), 25 on dialysis (CKD stage 5D) and 25 with kidney transplant (CKD-T) compared to 100 age-, sex- and BP-matched controls. Controls will be sourced from existing funded studies performing similar measurements on young people with primary hypertension and healthy normotensive controls, allowing the investigators to match CKD participants to a control group from across the blood pressure (BP) spectrum.
Longitudinal follow-up for one additional timepoint will be offered to all CKD participants with BP >75th percentile (or >130/80 mmHg in adults). The investigators expect this to be around 25 children and young people over the study time period.
All participants will undergo the following investigations:
- 24-hour ambulatory BP.
- Blood and urine tests for standard CKD biochemistry, hypertension biomarkers, cardiovascular risk profile and proteinuria.
- Arterial applanation tonometry.
- Cardiac and aortic MRI.
- Echocardiography.
- Height, weight and clinical BP.
- Tanita body composition.
Assessments will then be repeated in the CKD study group once BP <75th percentile (or <130/80 mmHg in adults) is achieved.
In a subset of study participants (n = 25 for each additional intervention), some additional investigations will be performed optionally at the discretion of researchers, patients and families:
- Respiratory effort with applanation tonometry before and after effort.
- Device guided slow breathing.
- Lower limb venous occlusion.
Study visits:
Potential participants will be identified from established CKD clinics and recruited with the help of a study coordinator based at Evelina London Children's Hospital (ELCH). Young adults with CKD will be recruited with the help of the well-established transition and adult CKD clinic at Guy's Hospital, with whom there are long- standing collaborations. Routinely, most children with moderate CKD will be seen at least once every 3-6 months.
Control participants will be included from a contemporaneously funded parallel study and include both children with primary hypertension and healthy normotensive children who have consented for their anonymised research data to be used in other ethically approved studies.
The investigators anticipate study consent and some routine clinic testing to be performed at the time of a planned clinic visit but detailed research related investigations including MRI may require an additional planned study visit lasting 2-4 hours at baseline and again at follow up for each complete set of research investigations. Visits will be conducted at dedicated child and adult Clinical Research Facilities as appropriate.
Participants will visit their usual hospital, have no extra needle pricks for blood tests, have non-invasive research tests offered at flexible timings and be compensated for their time and travel.
As this is an observational study, no study related change in the management of participants will be made.
Following achievement of clinical BP target (<75th percentile or <130/80mmHg in adults), assessments similar to baseline will be repeated in all participants and experimental interventions in a subset.
Sample size determination and statistical analysis:
Primary outcome: The mean difference in cfPWV between CYP with pre-dialysis CKD and age/sex/BP matched controls is expected to be ~ 0.8 m/s and with n = 50 in each group and a between-subject SD of 0.7 m/s (in-house from our HOT KID controls), the study will have 80% power (for p < 0.05) of detecting a difference > 0.4 m/s.
Interventional studies: a sample size n = 25 has similar power to detect a change >0.6 of the within-subject SD for differences in cfPWV, which for a within-subject SD of 0.5 m/s is 0.3 m/s, approximately 50% of the difference between hypertensive and normotensive CYP with CKD.
Longitudinal follow-up: within-subject SD is expected to be slightly greater, but this is offset by the greater sample size, and the investigators expect power to be similar to detect a change of 0.3 m/s, 50% of the difference between CYP with CKD and age-, sex- and BP-matched controls.
Recruitment of dialysis and transplant patients is exploratory at this stage and will generate pilot data, therefore for this study they were not included in the power calculation.
The primary outcome measure will be assessed by students t test and ANOVA, with and without adjustment for confounders including age, sex, ethnicity, renal function, heart rate, use of antihypertensive and BMI.
Effects of interventions and change in outcomes after follow-up will be assessed by repeated measures ANOVA.
Significance is defined as P < 0.05.
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- Chronic kidney disease, Hypertension, Arterial stiffness, Children, Pulse wave velocity, Cardiac MRI
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease | Children and young adults with chronic kidney disease: * 50 pre-dialysis (CKD stage 1-5) * 25 on dialysis (CKD stage 5D) * 25 with kidney transplant (CKD-T). | |
| Controls | sex and BP matched control participants comprising both young people with primary hypertension and healthy normotensive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single time point)
Secondary outcomes (5)
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.
Measured: 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).
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)
Measured: Baseline (single time point)
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.
Measured: Baseline (single time point)
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
Measured: Baseline (single time point)
Difference in cardiac output - Cardiac MRI
The difference in cardiac output between CYP with CKD and age, sex and BP matched controls as measured by: Cardiac MRI
Measured: Baseline (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start16 Jun 2026
- Primary completion16 Jun 2028 (estimated)
- Study completion16 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Manish Sinha, PhD, MBBS, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768865
- Sponsor's protocol ID
- 350147
- Acronym
- ART-KIDS
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared beyond the study team.
Publications
Gaddum NR, Keehn L, Guilcher A, Gomez A, Brett S, Beerbaum P, Schaeffter T, Chowienczyk P. Altered dependence of aortic pulse wave velocity on transmural pressure in hypertension revealing structural change in the aortic wall. Hypertension. 2015 Feb;65(2):362-9. doi: 10.1161/HYPERTENSIONAHA.114.04370. Epub 2014 Nov 17.
PubMed 25403607Gu H, Azukaitis K, Doyon A, Erdem S, Ranchin B, Harambat J, Lugani F, Boguslavskyi A, Cansick J, Finlay E, Gilbert R, Kerecuk L, Lunn A, Maxwell H, Morgan H, Shenoy M, Shroff R, Subramaniam P, Tizard J, Tse Y, Simpson J, Chowienczyk P, Schaefer F, Sinha MD; HOT-KID study, 4C Study Consortium. Decline in Left Ventricular Early Systolic Function with Worsening Kidney Function in Children with Chronic Kidney Disease: Insights from the 4C and HOT-KID Studies. J Am Soc Echocardiogr. 2024 Mar;37(3):356-363.e1. doi: 10.1016/j.echo.2023.11.013. Epub 2023 Nov 21.
PubMed 37993063Sinha MD, Gu H, Douiri A, Cansick J, Finlay E, Gilbert R, Kerecuk L, Lunn A, Maxwell H, Morgan H, Shenoy M, Shroff R, Subramaniam P, Tizard J, Tse Y, Rezavi R, Simpson JM, Chowienczyk PJ; HOT-KID study. Intensive compared with less intensive blood pressure control to prevent adverse cardiac remodelling in children with chronic kidney disease (HOT-KID): a parallel-group, open-label, multicentre, randomised, controlled trial. Lancet Child Adolesc Health. 2023 Jan;7(1):26-36. doi: 10.1016/S2352-4642(22)00302-9. Epub 2022 Nov 25.
PubMed 36442482Klein IH, Ligtenberg G, Neumann J, Oey PL, Koomans HA, Blankestijn PJ. Sympathetic nerve activity is inappropriately increased in chronic renal disease. J Am Soc Nephrol. 2003 Dec;14(12):3239-44. doi: 10.1097/01.asn.0000098687.01005.a5.
PubMed 14638922Grassi G, Quarti-Trevano F, Seravalle G, Arenare F, Volpe M, Furiani S, Dell'Oro R, Mancia G. Early sympathetic activation in the initial clinical stages of chronic renal failure. Hypertension. 2011 Apr;57(4):846-51. doi: 10.1161/HYPERTENSIONAHA.110.164780. Epub 2011 Feb 7.
PubMed 21300663Bruno RM, Ghiadoni L, Seravalle G, Dell'oro R, Taddei S, Grassi G. Sympathetic regulation of vascular function in health and disease. Front Physiol. 2012 Jul 24;3:284. doi: 10.3389/fphys.2012.00284. eCollection 2012.
PubMed 22934037Walther FJ, Siassi B, King J, Wu PY. Normal values of aortic root measurements in neonates. Pediatr Cardiol. 1985;6(2):61-3. doi: 10.1007/BF02282739.
PubMed 4059069Mu M, Wang SF, Sheng J, Zhao Y, Li HZ, Hu CL, Tao FB. Birth weight and subsequent blood pressure: a meta-analysis. Arch Cardiovasc Dis. 2012 Feb;105(2):99-113. doi: 10.1016/j.acvd.2011.10.006. Epub 2012 Feb 14.
PubMed 22424328Holwerda SW, Luehrs RE, DuBose L, Collins MT, Wooldridge NA, Stroud AK, Fadel PJ, Abboud FM, Pierce GL. Elevated Muscle Sympathetic Nerve Activity Contributes to Central Artery Stiffness in Young and Middle-Age/Older Adults. Hypertension. 2019 May;73(5):1025-1035. doi: 10.1161/HYPERTENSIONAHA.118.12462.
PubMed 30905199Faconti L, Farukh B, McNally R, Webb A, Chowienczyk P. Arterial Stiffness Can Be Modulated by Pressure-Independent Mechanisms in Hypertension. J Am Heart Assoc. 2019 Aug 6;8(15):e012601. doi: 10.1161/JAHA.119.012601. Epub 2019 Aug 5.
PubMed 31379238Li Y, Haseler E, McNally R, Sinha MD, Chowienczyk PJ. A meta-analysis of the haemodynamics of primary hypertension in children and adults. J Hypertens. 2023 Feb 1;41(2):212-219. doi: 10.1097/HJH.0000000000003326. Epub 2022 Dec 2.
PubMed 36583348Boutouyrie P, Chowienczyk P, Humphrey JD, Mitchell GF. Arterial Stiffness and Cardiovascular Risk in Hypertension. Circ Res. 2021 Apr 2;128(7):864-886. doi: 10.1161/CIRCRESAHA.121.318061. Epub 2021 Apr 1.
PubMed 33793325Azukaitis K, Kirchner M, Doyon A, Litwin M, Bayazit A, Duzova A, Canpolat N, Jankauskiene A, Shroff R, Melk A, Querfeld U, Schaefer F; 4C Study Investigators. Arterial Stiffness and Chronic Kidney Disease Progression in Children. Clin J Am Soc Nephrol. 2022 Oct;17(10):1467-1476. doi: 10.2215/CJN.02200222. Epub 2022 Aug 25.
PubMed 36008353Shroff RC, Donald AE, Hiorns MP, Watson A, Feather S, Milford D, Ellins EA, Storry C, Ridout D, Deanfield J, Rees L. Mineral metabolism and vascular damage in children on dialysis. J Am Soc Nephrol. 2007 Nov;18(11):2996-3003. doi: 10.1681/ASN.2006121397. Epub 2007 Oct 17.
PubMed 17942964Litwin M, Wuhl E, Jourdan C, Trelewicz J, Niemirska A, Fahr K, Jobs K, Grenda R, Wawer ZT, Rajszys P, Troger J, Mehls O, Schaefer F. Altered morphologic properties of large arteries in children with chronic renal failure and after renal transplantation. J Am Soc Nephrol. 2005 May;16(5):1494-500. doi: 10.1681/ASN.2004110932. Epub 2005 Mar 16.
PubMed 15772249
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness in Children and Young People With Hypertension and Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07768865
- Acronym / sponsor ID
- ART-KIDS / 350147
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- Chronic kidney disease, Hypertension, Arterial stiffness, Children, Pulse wave velocity, Cardiac MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 16 Jun 2028 (estimated)
- Study completion
- 16 Jun 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Methods:
Single time point assessment of aortic stiffness of children and young people with CKD; recruitment target of in total 100 participants, of which: 50 pre-dialysis (CKD stage 1-5), 25 on dialysis (CKD stage 5D) and 25 with kidney transplant (CKD-T) compared to 100 age-, sex- and BP-matched controls. Controls will be sourced from existing funded studies performing similar measurements on young people with primary hypertension and healthy normotensive controls, allowing the investigators to match CKD participants to a control group from across the blood pressure (BP) spectrum.
Longitudinal follow-up for one additional timepoint will be offered to all CKD participants with BP >75th percentile (or >130/80 mmHg in adults). The investigators expect this to be around 25 children and young people over the study time period.
All participants will undergo the following investigations:
- 24-hour ambulatory BP.
- Blood and urine tests for standard CKD biochemistry, hypertension biomarkers, cardiovascular risk profile and proteinuria.
- Arterial applanation tonometry.
- Cardiac and aortic MRI.
- Echocardiography.
- Height, weight and clinical BP.
- Tanita body composition.
Assessments will then be repeated in the CKD study group once BP <75th percentile (or <130/80 mmHg in adults) is achieved.
In a subset of study participants (n = 25 for each additional intervention), some additional investigations will be performed optionally at the discretion of researchers, patients and families:
- Respiratory effort with applanation tonometry before and after effort.
- Device guided slow breathing.
- Lower limb venous occlusion.
Study visits:
Potential participants will be identified from established CKD clinics and recruited with the help of a study coordinator based at Evelina London Children's Hospital (ELCH). Young adults with CKD will be recruited with the help of the well-established transition and adult CKD clinic at Guy's Hospital, with whom there are long- standing collaborations. Routinely, most children with moderate CKD will be seen at least once every 3-6 months.
Control participants will be included from a contemporaneously funded parallel study and include both children with primary hypertension and healthy normotensive children who have consented for their anonymised research data to be used in other ethically approved studies.
The investigators anticipate study consent and some routine clinic testing to be performed at the time of a planned clinic visit but detailed research related investigations including MRI may require an additional planned study visit lasting 2-4 hours at baseline and again at follow up for each complete set of research investigations. Visits will be conducted at dedicated child and adult Clinical Research Facilities as appropriate.
Participants will visit their usual hospital, have no extra needle pricks for blood tests, have non-invasive research tests offered at flexible timings and be compensated for their time and travel.
As this is an observational study, no study related change in the management of participants will be made.
Following achievement of clinical BP target (<75th percentile or <130/80mmHg in adults), assessments similar to baseline will be repeated in all participants and experimental interventions in a subset.
Sample size determination and statistical analysis:
Primary outcome: The mean difference in cfPWV between CYP with pre-dialysis CKD and age/sex/BP matched controls is expected to be ~ 0.8 m/s and with n = 50 in each group and a between-subject SD of 0.7 m/s (in-house from our HOT KID controls), the study will have 80% power (for p < 0.05) of detecting a difference > 0.4 m/s.
Interventional studies: a sample size n = 25 has similar power to detect a change >0.6 of the within-subject SD for differences in cfPWV, which for a within-subject SD of 0.5 m/s is 0.3 m/s, approximately 50% of the difference between hypertensive and normotensive CYP with CKD.
Longitudinal follow-up: within-subject SD is expected to be slightly greater, but this is offset by the greater sample size, and the investigators expect power to be similar to detect a change of 0.3 m/s, 50% of the difference between CYP with CKD and age-, sex- and BP-matched controls.
Recruitment of dialysis and transplant patients is exploratory at this stage and will generate pilot data, therefore for this study they were not included in the power calculation.
The primary outcome measure will be assessed by students t test and ANOVA, with and without adjustment for confounders including age, sex, ethnicity, renal function, heart rate, use of antihypertensive and BMI.
Effects of interventions and change in outcomes after follow-up will be assessed by repeated measures ANOVA.
Significance is defined as P < 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | –Children and young adults with chronic kidney disease: * 50 pre-dialysis (CKD stage 1-5) * 25 on dialysis (CKD stage 5D) * 25 with kidney transplant (CKD-T). |
| Controls | – | –sex and BP matched control participants comprising both young people with primary hypertension and healthy normotensive |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults with chronic kidney disease and age-, sex- and gender-matched healthy controls and those with primary hypertension.
Key inclusion criteria (7 listed)
- 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
- Having completed study measurements as part of other research being completed by the research group and having consented to their anonymised data being used in future research within the same research theme.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in carotid femoral pulse wave velocity
Time frame: Baseline (single time point)
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.
5 secondary outcomes
Difference in carotid femoral pulse wave velocity once blood pressure is normalised
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).
Difference in sympathetic nerve activity
Time frame: Baseline (single time point)
Difference in aortic pulse wave velocity
Time frame: Baseline (single time point)
Difference in cardiac output - echocardiography
Time frame: Baseline (single time point)
Difference in cardiac output - Cardiac MRI
Time frame: Baseline (single time point)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 25403607Gaddum NR, Keehn L, Guilcher A, Gomez A, Brett S, Beerbaum P, Schaeffter T, Chowienczyk P. Altered dependence of aortic pulse wave velocity on transmural pressure in hypertension revealing structural change in the aortic wall. Hypertension. 2015 Feb;65(2):362-9. doi: 10.1161/HYPERTENSIONAHA.114.04370. Epub 2014 Nov 17.
- Background: PubMed 37993063Gu H, Azukaitis K, Doyon A, Erdem S, Ranchin B, Harambat J, Lugani F, Boguslavskyi A, Cansick J, Finlay E, Gilbert R, Kerecuk L, Lunn A, Maxwell H, Morgan H, Shenoy M, Shroff R, Subramaniam P, Tizard J, Tse Y, Simpson J, Chowienczyk P, Schaefer F, Sinha MD; HOT-KID study, 4C Study Consortium. Decline in Left Ventricular Early Systolic Function with Worsening Kidney Function in Children with Chronic Kidney Disease: Insights from the 4C and HOT-KID Studies. J Am Soc Echocardiogr. 2024 Mar;37(3):356-363.e1. doi: 10.1016/j.echo.2023.11.013. Epub 2023 Nov 21.
- Background: PubMed 36442482Sinha MD, Gu H, Douiri A, Cansick J, Finlay E, Gilbert R, Kerecuk L, Lunn A, Maxwell H, Morgan H, Shenoy M, Shroff R, Subramaniam P, Tizard J, Tse Y, Rezavi R, Simpson JM, Chowienczyk PJ; HOT-KID study. Intensive compared with less intensive blood pressure control to prevent adverse cardiac remodelling in children with chronic kidney disease (HOT-KID): a parallel-group, open-label, multicentre, randomised, controlled trial. Lancet Child Adolesc Health. 2023 Jan;7(1):26-36. doi: 10.1016/S2352-4642(22)00302-9. Epub 2022 Nov 25.
- Background: PubMed 14638922Klein IH, Ligtenberg G, Neumann J, Oey PL, Koomans HA, Blankestijn PJ. Sympathetic nerve activity is inappropriately increased in chronic renal disease. J Am Soc Nephrol. 2003 Dec;14(12):3239-44. doi: 10.1097/01.asn.0000098687.01005.a5.
- Background: PubMed 21300663Grassi G, Quarti-Trevano F, Seravalle G, Arenare F, Volpe M, Furiani S, Dell'Oro R, Mancia G. Early sympathetic activation in the initial clinical stages of chronic renal failure. Hypertension. 2011 Apr;57(4):846-51. doi: 10.1161/HYPERTENSIONAHA.110.164780. Epub 2011 Feb 7.
- Background: PubMed 22934037Bruno RM, Ghiadoni L, Seravalle G, Dell'oro R, Taddei S, Grassi G. Sympathetic regulation of vascular function in health and disease. Front Physiol. 2012 Jul 24;3:284. doi: 10.3389/fphys.2012.00284. eCollection 2012.
- Background: PubMed 4059069Walther FJ, Siassi B, King J, Wu PY. Normal values of aortic root measurements in neonates. Pediatr Cardiol. 1985;6(2):61-3. doi: 10.1007/BF02282739.
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- Individual participant dataSharing planned: No. IPD will not be shared beyond the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manish Sinha, PhD, MBBS principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Hypertension, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Boxer, BSc, PhD (+44 20 7188 4770, benjamin.boxer@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in carotid femoral pulse wave velocity (time frame: Baseline (single time point)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07768865, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.