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

NCT01007994 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-04-13

Study results available
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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).

Conditions

  • Hypertension Secondary to Kidney Transplant

Interventions

DRUG

New Medication: Enalapril, Isradipine, Propranolol

Enalapril will be added in the evening at 8 pm. If the subject is already on an ACEI or there is a contraindication to starting an ACEI the subject will be started on isradipine instead. If the subject is already on an ACEI and calcium channel blocker at baseline, propranolol will then be the new medication added. Dosing will be as follows: ACEI: Enalapril \< 40 kg starting dose 2.5 mg titrate to 5 mg \> 40 kg starting dose 5 mg titrate to 10mg Calcium Channel Blocker: Isradipine \< 40 kg 2.5 mg \> 40 kg starting dose 2.5 mg titrate to 5 mg Beta Blocker: Propranolol \<40 kg starting dose 10 mg titrate to 20 mg \>40 kg starting dose 20 mg titrate to 40 mg

Sponsors & Collaborators

Principal Investigators

  • Christine B Sethna, MD, EdM · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2020-01-31
Completion
2020-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01007994 on ClinicalTrials.gov