Chronotherapy in Children With Chronic Kidney Disease

Hypertension Clinical Trial

Official title:

Investigating if Nocturnal Blood Pressure Patterns Are Modifiable in Children With Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353335
• Other study ID #: 2000031575
• Secondary ID: 1K23DK129836-01
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Christine Bakhoum, MD, MAS
• Phone: 2037376095
• Email: christine.bakhoum[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot, crossover trial in which the investigator will determine if retiming of one anti-hypertensive medication from morning to evening can effectuate normal blood pressure dipping patterns in children and adolescents with chronic kidney disease.

Description:

Normally blood pressure declines by at least 10% from daytime to nighttime. In children with chronic kidney disease (CKD), often this does not happen (termed "non-dipping"). This study is a pilot, randomized cross-over trial. The main purpose of this study is to investigate whether non-dipping can be modified with retiming of anti-hypertensives in children with CKD. This is important because in adults, non-dipping has been associated with increased cardiovascular disease risk and more rapid progression of kidney disease. Thus, identification of how to modify this in children with CKD, may lead to future randomized controlled trials to evaluate whether chronotherapy improves outcomes in this population, which is at high risk for morbidity and mortality in adulthood.

The primary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal systolic blood pressure change (%) in children with CKD, hypertension and non-dipping.

The secondary objective of this study is to determine whether retiming of one anti-hypertensive to the evening will increase nocturnal diastolic blood pressure change (%) in children with CKD, hypertension and non-dipping. Another secondary objective is to determine if the proportion of subjects classified as having a non-dipping pattern is significantly lower on evening dosing of anti-hypertensives.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Male or female child/adolescent up to 18 years of age with CKD

• estimated glomerular filtration rate (eGFR) of 30 to 90 ml/min/1.73 m2

• diagnosed with hypertension and on a stable dose of anti-hypertensive medication(s) for at least 3 months

• Non-dipping identified on ABPM

Exclusion Criteria:

• history of organ transplantation, oncological disease, or dialysis

• inability to complete 24-hour ABPM or 24-hour urine collection

• Children less than 6 years of age will be excluded, as they often are unable to complete a successful ABPM study (= 40 readings, with 1 reading per hour of sleep)

• Currently on diuretic medications.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Re-timing of anti-hypertensive drug
The intervention will consist of shifting the anti-hypertensive medication from morning/early dose to an evening/later dose
• Current regimen
The participants will begin on their current regimen.

Locations

Country	Name	City	State
United States	Yale New Haven Children's Hospital/Yale New Haven Health	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	American Heart Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in nocturnal systolic blood pressure in participants administered anti-hypertensive medications at night on Ambulatory blood pressure monitor(ing) (ABPM).	Percent change in systolic nocturnal blood pressure will be calculated as : (daytime mean SBP - nighttime mean SBP)/daytime mean SBP x 100 to assess if nocturnal BP dipping can be restored.	Baseline and Month 1
Secondary	Percent change in nocturnal diastolic blood pressure in participants administered anti-hypertensive medications at night on ABPM.	Percent change in systolic nocturnal blood pressure will be calculated as: (daytime mean DBP - nighttime mean DBP)/daytime mean DBP x 100 to assess if nocturnal BP dipping can be restored.	Baseline and Month 1
Secondary	Change in proportion of participants with restoration of dipping while on the intervention, defined as <10% systolic or diastolic nocturnal blood pressure change	This outcome will assess if the proportion of subjects classified as having a non-dipping pattern is significantly lower on evening dosing of anti-hypertensives. Restoration of dipping would mean that both systolic and diastolic nocturnal blood pressure change are greater than or equal to 10%, after the intervention.	Baseline and Month 1