The Hypertension Optimal Treatment in Children with Chronic Kidney Disease study
| ISRCTN | ISRCTN25006406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25006406 |
| Secondary identifying numbers | 12925 |
- Submission date
- 16/08/2012
- Registration date
- 16/08/2012
- Last edited
- 24/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work effectively. With modern treatments and advancements in dialysis, increasing numbers of children with CKD are surviving through childhood and early adulthood. Thereafter, however, heart disease becomes one of the major causes of death in these young adults. Restoring kidney function by transplantation reduces but does not eliminate this increased risk and arterial disease (narrowing of the arteries) in these adults is likely to relate to preclinical disease developing during childhood. In adult patients with CKD lowering blood pressure has been found to have a beneficial effect on both heart and kidney outcomes, with suitable recommendations from expert groups and international committees. Recommendations for children with CKD differ, with current recommendations to maintain blood pressure within the normal range for the child’s age, gender and height. The aim of this study is to determine the relationship between left ventricular mass and hypertrophy (increase in size of the left side of the heart), arterial function and structure with the severity and duration of childhood CKD, and to examine the relationship of these measures to blood pressure. We will also determine whether aggressive blood pressure reduction is effective at normalising left ventricular hypertrophy, arterial function and structure.
Who can participate?
CKD patients aged 2 to 15 years, and children with normal kidney function and blood pressure attending hospital for an unrelated medical review or the siblings of patients with CKD.
What does the study involve?
CKD patients are randomly allocated to either aggressive blood pressure reduction or standard care (maintain blood pressure within the normal range). The differences in left ventricular mass and arterial function and structure are measured after 2 and 4 years.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
St Thomas's Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2012 to July 2017
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Dr Manish Sinha
Manish.Sinha@gstt.nhs.uk
Contact information
Scientific
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
| Manish.Sinha@gstt.nhs.uk |
Study information
| Study design | Randomized interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The Hypertension Optimal Treatment in Children with Chronic Kidney Disease study: the HOT-KID study - a randomised trial to compare effects of aggressive versus standard targets in blood pressure on target organ damage in children with CKD |
| Study acronym | HOT-KID |
| Study objectives | The aim of this project is to: 1. Determine the association of left ventricular mass and hypertrophy (LVH), arterial function and structure with severity and duration of childhood CKD and to examine the relation of these measures to blood pressure 2. Perform a randomised controlled trial to determine whether aggressive blood pressure reduction (below 40th percentile) compared to standard care (between 50th-75th percentile) is effective in normalising left ventricular hypertrophy, arterial function and structure, improves urinary protein excretion 3. Establish a cohort of children with CKD to be followed prospectively to determine predictors of progression of CKD, subclinical and clinical cardiovascular disease. More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12925 |
| Ethics approval(s) | ref: 10/H0802/13 |
| Health condition(s) or problem(s) studied | Chronic kidney disease |
| Intervention | Description: 150 subjects for randomisation and n=150 age matched controls Blood pressure control, Control of clinic systolic blood pressure to target using ACEi therapy as first line agent. Followed up at 5 months |
| Intervention type | Other |
| Primary outcome measure | The differences in LV mass between aggressive and standard treatment groups measured at 2 and 4 years |
| Secondary outcome measures | Differences in cIMT and PWV measured at 2 and 4 years |
| Overall study start date | 08/08/2012 |
| Completion date | 31/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 300 |
| Total final enrolment | 124 |
| Key inclusion criteria | 1. Aged 2 to 15 years 2. Chronic kidney disease with eGFR between 15-90 ml/min/1.73m2 for two consecutive measurements in the last 12 months 3. With or without anti-hypertensive/s medications (irrespective of recent change/s in antihypertensive therapy) 4. Subjects with average clinic systolic BP <50th percentile and on no antihypertensive medication will be eligible as CONTROL subjects only 5. Other CONTROL subjects will include children with normal renal function and blood pressure attending hospital for unrelated medical review or siblings of subjects with CKD 6. Male and female participants |
| Key exclusion criteria | 1. Age <2 and >15 years 2. Subjects who have/had an arterio-venous fistulae 3. Subjects who have/had are on dialysis 4. Subjects who have/had a functioning kidney transplant 5. Patients with symptomatic BP or with past history of difficulty to control BP or 6. Patients in whom there is a clinical urgency to treat BP and inclusion in study may result inpossible delay of treatment 7. Patients with arrhythmia or clinical heart failure 8. Patients with known structural cardiac abnormality 9. Subjects on treatment with angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) agents for treatment of proteinuria only or 10. Subjects who are likely to be of clinical concern following up or down titration of BP levels as described in Appendix 3 11. Subjects who are unable or intolerant to performance of study measurements e.g. height, echo or PWV 12. Subjects who have/had intolerance to Angiotensin converting enzyme inhibitors (ACEi) drug/s or have any existing contraindications |
| Date of first enrolment | 08/08/2012 |
| Date of final enrolment | 24/07/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 7EH
United Kingdom
Sponsor information
Hospital/treatment centre
Thomas Guy House
Lambeth Palace Road
London
SE1 7EH
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/11/2022 | 29/11/2022 | Yes | No | |
| Other publications | 21/04/2025 | 24/04/2025 | Yes | No |
Editorial Notes
24/04/2025: Publication reference added.
29/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
24/04/2020: An intention to publish date has been added.
29/11/2018: The overall trial end date has been changed from 24/07/2017 to 31/03/2019.
18/02/2016: Plain English summary added.
