Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Manish Sinha
ORCID ID
Contact details
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
-
Manish.Sinha@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12925
Study information
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
Acronym
HOT-KID
Study hypothesis
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
ref: 10/H0802/13
Study design
Randomised interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
08/08/2012
Overall trial end date
24/07/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
UK Sample Size: 300
Participant 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
Recruitment start date
08/08/2012
Recruitment end date
24/07/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas's Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St. Thomas' NHS Foundation Trust (UK)
Sponsor details
Thomas Guy House
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary