Retiming blood pressure medication in children with chronic kidney disease
Investigating if Nocturnal Blood Pressure Patterns Are Modifiable in Children With Chronic Kidney Disease
This study is testing if giving blood pressure medicine in the evening instead of the morning can help children with chronic kidney disease have better blood pressure patterns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05353335 on ClinicalTrials.gov |
What this trial studies
This pilot, crossover trial aims to determine if changing the timing of an anti-hypertensive medication from morning to evening can improve blood pressure patterns in children and adolescents with chronic kidney disease (CKD). The study focuses on children who experience non-dipping of blood pressure, a condition linked to increased cardiovascular risks. Participants will be monitored to assess changes in nocturnal blood pressure after the retiming of their medication. The findings could pave the way for future studies on chronotherapy in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents up to 18 years old with chronic kidney disease, hypertension, and a non-dipping blood pressure pattern.
Not a fit: Patients with a history of organ transplantation, oncological disease, or those currently on diuretic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved blood pressure regulation and reduced cardiovascular risks in children with chronic kidney disease.
How similar studies have performed: While this approach is novel in the pediatric CKD population, similar studies in adults have shown that chronotherapy can positively impact blood pressure management.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut
- Yale New Haven Children's Hospital/Yale New Haven Health — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Christine Bakhoum — Yale University
- Study coordinator: Christine Bakhoum, MD, MAS
- Email: christine.bakhoum@yale.edu
- Phone: 2037376095
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.