Reduction of Night-time Blood Pressure in Pediatric Renal Transplant Recipients

• Status: Completed
• Trial end date: 2020-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study investigated the effect of chronotherapeutic alteration of anti-hypertensive medication on nocturnal hypertension and end-organ injury in pediatric renal transplant recipients who are non-dippers. Additionally, the investigators examined the association between response to intervention, serum adiponectin levels and adiponectin gene polymorphisms. The investigators hypothesized that (1) evening administration of anti-hypertensive medication will convert subjects from non-dipper to dipper status, improve mean nocturnal blood pressure (BP), and improve nocturnal BP load, (2) evening administration of anti-hypertensive medication will reduce albuminuria, left ventricular mass index (LVMI), rate of decline of glomerular filtration rate (eGFR) and will decrease pulse wave velocity (PWV).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Collaborator: Children's Hospital of Philadelphia
• Treatments: Calcium Channel Blockers; Enalapril; Enalaprilat; Isradipine; Propranolol

Criteria

Inclusion Criteria:

• Subjects age 5-21 years

• Stable kidney transplant recipients (<30% change in eGFR in past 3 months)

• eGFR > 30 ml/min/1.73 m2

• >6 months since kidney transplant

• ABPM: Non-dipper status defined as <10% decline in systolic or diastolic blood pressure from daytime to night-time

Exclusion Criteria:

• ABPM: Subjects with daytime mean blood pressure > 95% for height and sex

• Subjects on diuretic monotherapy will not be eligible for the time change group (to avoid discomfort of nocturnal enuresis)

• Subjects with nephrotic range proteinuria

• Subjects with major co-morbid conditions such as cardiac disease, pulmonary disease and diabetes mellitus

• Subjects/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

• Subjects who are pregnant will not be eligible for the new medication group