Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to test whether n-of-1 trial-guided clinical decision-making improves blood pressure control in hypertensive children with chronic kidney disease (CKD) and end-stage renal disease (ESRD).

Official Title
-----------------
Assessing the Feasibility of N-of-1 Trials in Children With Hypertension and Chronic Kidney Disease: a Pilot Study

Conditions
-----------------
Hypertension, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Procedure: n-of-1 trial guided clinical decision making


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypertension CKD stage 2-5 requiring antihypertensive medication per clinician judgement. Exclusion Criteria: renal transplant anticipated or occurred within 6 months of screening transfer out of our practice setting anticipated within 6 months unable to complete 24 hour arterial blood pressure monitoring (ABPM) due to developmental or behavioral limitations

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: n-of-1 trial guided clinical decision making<br> | Procedure: n-of-1 trial guided clinical decision making<br>* The n-of-1 trial will, on the level of the individual patient, test which treatment strategy produces superior blood pressure reduction without unacceptable side effects. After discussion with the patient/caregiver dyad to identify whether they have specific concerns about particular medications, the nephrologist (clinician) will decide which two drugs and dosages will be tested in the n-of-1 trial (the protocol does not determine drug or dose). The two drugs chosen by the clinician will be assessed at clinician-selected dosing in a randomized treatment order (e.g., ABAB) for two weeks per treatment period and two treatment periods per drug.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour Mean Arterial Pressure (MAP) | 24-hour mean arterial pressure (MAP) is the mean arterial pressure over 24 hours [ambulatory blood pressure monitoring (ABPM) will be used to record blood pressure every 20 min for 24 hours, and all recordings will be averaged to obtain 24-hour MAP]. 24-hour MAP will be assessed at baseline and at 6 months, and the change between baseline and 6-months will be reported. | baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Target Blood Pressure | Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile. | 6 months | 
| Number of Participants With Target Blood Pressure | Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
n-of-1 trial