Clinical trial NCT05353335: Chronotherapy in Children With Chronic Kidney Disease
Official title: Investigating if Nocturnal Blood Pressure Patterns Are Modifiable in Children With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Kidney Diseases
Hypertension
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: American Heart Association
First posted: 2022-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent change in nocturnal systolic blood pressure in participants administered anti-hypertensive medications at night on Ambulatory blood pressure monitor(ing) (ABPM).
timeFrame: Baseline and Month 1
Secondary outcomes:
measure: Percent change in nocturnal diastolic blood pressure in participants administered anti-hypertensive medications at night on ABPM.
timeFrame: Baseline and Month 1
measure: Change in proportion of participants with restoration of dipping while on the intervention, defined as <10% systolic or diastolic nocturnal blood pressure change
timeFrame: Baseline and Month 1
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Children's Hospital/Yale New Haven Health
state: Connecticut
Study officials:
affiliation: Yale University
name: Christine Bakhoum
role: PRINCIPAL_INVESTIGATOR
References: