Reduction of Night-time Blood Pressure in Pediatric Renal Transplant Recipients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 5 - 21 |
| Updated: | 5/30/2018 |
| Start Date: | November 2009 |
| End Date: | December 2018 |
Reduction of Nocturnal Hypertension in Pediatric Renal Transplant Recipients
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.
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.
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
We found this trial at
2
sites
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Kevin EC Meyers, MbbCh
Phone: 215-590-2449
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
Click here to add this to my saved trials
New Hyde Park, New York 11040
Principal Investigator: Christine B Sethna, MD, EdM
Phone: 718-470-3423
Click here to add this to my saved trials