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

Not Applicable

Completed

• Conditions: Hypertension; Chronic Kidney Diseases
• Interventions: Procedure: n-of-1 trial guided clinical decision making

• Registration Number: NCT04591171
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Study Start: 2021-01-25
• Primary Completion: 2022-02-18
• Study Completion: 2022-02-18
• Status Verified: 2023-02
• Results First Submitted: 2023-02-17
• Results First Submitted QC: 2023-02-17
• Last Update Submitted: 2023-02-17
• Results First Posted: 2023-03-20
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
n-of-1 trial guided clinical decision making	n-of-1 trial guided clinical decision making	-

Primary Outcome Measures

Name	Time	Method
Change in 24-hour Mean Arterial Pressure (MAP)	baseline, 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Target Blood Pressure	baseline	Target blood pressure is 24-hour mean arterial pressure (MAP) at less than the 50th percentile.

Trial Locations

Locations (1)

University of Texas at Houston Medical School; Pediatric Nephrology and Hypertension Clinics; 🇺🇸 Houston, Texas, United States