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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by North Shore Long Island Jewish Health System
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Christine B Sethna, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01007994
First received: November 4, 2009
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Hypertension Secondary to Kidney Transplant
Drug: New Medication: Enalapril, Isradipine, Propranolol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reduction of Nocturnal Hypertension in Pediatric Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Proportion of subjects in each of the treatment arms who change from non-dipper to dipper status [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in night-time systolic/diastolic blood pressure [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Change in left ventricular mass index [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Change in albumin:creatinine ratio [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Change in estimated glomerular filtration rate [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Change in pulse wave velocity [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Association of serum adiponectin levels and SNPs of adiponectin with outcomes [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: New Medication
A new anti-hypertensive medication (enalapril, propranolol or isradipine) will be added at 8pm.
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

Other Name: Vasotec, DynaCirc, Inderal
No Intervention: Control
Subjects in the control group will continue to take their medications as usual.

  Eligibility

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007994

Contacts
Contact: Christine B Sethna, MD, EdM 718-470-3423 csethna@nshs.edu

Locations
United States, New York
Cohen Children's Medical Center of NY Recruiting
New Hyde Park, New York, United States, 11040
Contact: Christine B Sethna, MD, EdM    718-470-3423    csethna@nshs.edu   
Principal Investigator: Christine B Sethna, MD, EdM         
Sub-Investigator: Howard Trachtman, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kevin EC Meyers, MbbCh    215-590-2449    meyersk@email.chop.edu   
Principal Investigator: Kevin EC Meyers, MbbCh         
Sub-Investigator: Cathy Laney, CRNP         
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Christine B Sethna, MD, EdM North Shore Long Island Jewish Health System
  More Information

No publications provided

Responsible Party: Christine B Sethna, MD, Interim Division Director, Pediatric Nephrology, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01007994     History of Changes
Other Study ID Numbers: 09-054
Study First Received: November 4, 2009
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Nocturnal hypertension
Pediatric
Renal Transplant
Pulse Wave Velocity
Echocardiogram
Pediatric Renal Transplant Recipient

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Isradipine
Propranolol
Enalapril
Enalaprilat
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014