Health TrialsbyHealthPanel

Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease

ConditionAutosomal Dominant Polycystic Kidney Disease (ADPKD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-17
SponsorKing's College London

About this trial

The goal of this project is to measure the prevalence of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and hypertension in the general population of children and young people at risk of ADPKD, using magnetic resonance imaging (MRI) for rapid diagnosis alongside genetic testing. The main question it aims to answer is:

What is the prevalence of hypertension in a population sample of adolescents with ADPKD?

Participants will have the following measurements performed:

* Height and weight. * Blood pressure. * Non-invasive measurement of arterial stiffness. * Cardiac and renal MRI. * Blood sample. * Genetic testing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 12 - 17 years at the time of consent

Able to tolerate the key study investigations (office blood pressure measurement, ambulatory blood pressure measurement, MRI and blood test)

Parent with confirmed clinical diagnosis of ADPKD

Parent (if child <16 years) or both parent and young person (if >=16 years) consents to genetic testing for ADPKD and demonstrates understanding of the implications of this.

Disqualifiers

18 years or above at the time of study entry

Unable to tolerate key study investigations

Presence of associated co-morbidities which make it difficult to interpret results, including congenital cardiac anomalies and known TSC-PKD1 mutations

Unwilling to undergo genetic testing for ADPKD

Trial population

General population of children and young people at risk of ADPKD

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: ADPKD positive
Group B: ADPKD negative

Trial outcomes

Primary outcomes

1

Number of participants with hypertension in general population of children and young people at risk of ADPKD.

Diagnosis of hypertension from clinic manual blood pressure and 24 hours ambulatory blood pressure measurement

Time frame
Day 1

Secondary outcomes

1

Number of participants diagnosed with ADPKD from renal MRI compared to the number from genetic testing.

Prevalence of ADPKD assessed by renal MRI compared to genetic testing

Time frame
Day 1
2

Number of participants with cyst negative but gene positive ADPKD in this age group.

Agreement between MRI and genetic testing for diagnosis of ADPKD.

Time frame
Day 1
3

Number of participants with abnormal albuminuria in the population at risk of ADPKD.

Presence of albuminuria in urine samples collected.

Time frame
Single time point
4

Central blood pressure in young people with ADPKD compared to healthy controls

Comparison between central aortic systolic and diastolic pressure (mmHg) measured by tonometry between participants with ADPKD and healthy controls

Time frame
Day 1

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

Source ClinicalTrials.gov
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