Reduction of Night-time Blood Pressure in Pediatric Renal Transplant Recipients
Information source: North Shore Long Island Jewish Health System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension Secondary to Kidney Transplant
Intervention: New Medication: Enalapril, Isradipine, Propranolol (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: North Shore Long Island Jewish Health System Official(s) and/or principal investigator(s): Christine B Sethna, MD, EdM, Principal Investigator, Affiliation: North Shore Long Island Jewish Health System
Overall contact: Christine B Sethna, MD, EdM, Phone: 718-470-3423, Email: csethna@nshs.edu
Summary
The proposed study will investigate 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 aim to
examine the association between response to intervention, serum adiponectin levels and
adiponectin gene polymorphisms. The investigators hypothesize 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), and (3) lower adiponectin levels and presence of
adiponectin gene polymorphisms will be associated with less of a response to the
intervention.
Clinical Details
Official title: Reduction of Nocturnal Hypertension in Pediatric Renal Transplant Recipients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Proportion of subjects in each of the treatment arms who change from non-dipper to dipper status
Secondary outcome: Change in night-time systolic/diastolic blood pressureChange in left ventricular mass index Change in albumin:creatinine ratio Change in estimated glomerular filtration rate Change in pulse wave velocity Association of serum adiponectin levels and SNPs of adiponectin with outcomes
Eligibility
Minimum age: 5 Years.
Maximum age: 21 Years.
Gender(s): Both.
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
Locations and Contacts
Christine B Sethna, MD, EdM, Phone: 718-470-3423, Email: csethna@nshs.edu
Cohen Children's Medical Center of NY, New Hyde Park, New York 11040, United States; Recruiting Christine B Sethna, MD, EdM, Phone: 718-470-3423, Email: csethna@nshs.edu Christine B Sethna, MD, EdM, Principal Investigator Howard Trachtman, MD, Sub-Investigator
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting Kevin EC Meyers, MbbCh, Phone: 215-590-2449, Email: meyersk@email.chop.edu Kevin EC Meyers, MbbCh, Principal Investigator Cathy Laney, CRNP, Sub-Investigator
Additional Information
Starting date: November 2009
Last updated: April 20, 2015
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