Condition category
Urological and Genital Diseases
Date applied
16/08/2012
Date assigned
16/08/2012
Last edited
18/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.guysandstthomas.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

18/02/2016: Plain English summary added.