Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

This study has been withdrawn prior to enrollment.
(primary investigator left institution; not enough patients)
Sponsor:
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01120613
First received: April 29, 2010
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

Hypertension (HTN) affects up to 75% of kidney transplant recipients and is associated with premature death. Nocturnal HTN is a common complication of ongoing essential HTN or a secondary cause of HTN. Both the non dipping of systolic blood pressure (SBP) at night time and the reverse dipping is associated with increased target organ damage and adverse cardiovascular outcomes and possibly allograft survival. Treatment of Nocturnal HTN is critical. Chronotherapy has been shown to be effective in halting progression in patients with diabetic nephropathy and chronic kidney disease. There is not enough data on prevalence and management of nocturnal HTN in transplant patients, which is the object of this study.


Condition Intervention
Hypertension
Drug: Chronotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent drop in mean SBP at night time compared to mean SBP at day time [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine Microalbumin to creatinine ratio [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Change in Glomerular filtration rate as measured by MDRD equation. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Serum creatinine as a measure of kidney function will be measured at the begining and end of intervention.

  • 24 hour mean systolic Blood Pressure (SBP) Control [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Ambulatory Blood pressure monitoring at the end of intervention will be used to assess 24 hour ( day and nighttime) blood pressure control We hypothesize that night time dosing of medication ( chronotherapy) will not only improve nocturnal hypertension but also improve awake blood pressure and overall 24 hour average SBP control.


Enrollment: 0
Study Start Date: April 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chronotherapy
Patients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing
Drug: Chronotherapy

Patients identified with nocturnal hypertension while treated with blood pressure medications will have one medication switched from daytime to night time dosing in the following preference:

  1. ACE or ARB
  2. Calcium Channel Blockers
  3. Alpha Blocker
  4. Beta Blocker

If patient is on only one daytime BP medication, it will be switched to night time dosing. No dose adjustments will be made nor any new medications will be added. Only timing of BP medication will be changed.


  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Renal transplant more than 1 year ago and not on dialysis.
  2. Age between 18 years to 70 years.
  3. Known history of HTN on one or more anti-hypertensive medication.
  4. Stable anti-hypertensive regimen for past 2 months
  5. One of the anti-hypertensive regimen must include an ACE inhibitor, or an angiotensin receptor blocker, calcium channel blocker, alpha or beta blocker.
  6. Stable immunosuppressive regimen with no dose changes in past 3 months.
  7. No hospitalizations for previous 2 months

Exclusion Criteria:

  1. Inability to consent
  2. History of falls
  3. Presence of AVF or AVG in both the arms
  4. Inability to follow up in renal transplant clinic.
  5. History of Atrial fibrillation.
  6. Pregnant Women
  7. Parkinson's Disease
  8. Severe orthostatic Hypotension
  9. Severe autonomic dysfunction
  10. History of other transplanted organs
  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: NCT01120613

Locations
United States, New York
North Shore Long Island Jewish Hospital
Great Neck, New York, United States, 11020
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Rajiv Vij, MD MPH North Shore Long Island Jewish Hospital
Principal Investigator: Kenar Jhaveri, MD North Shore Long Island Jewish Hospital
  More Information

Publications:

Responsible Party: Rajiv Vij MD MPH, North Shore LIJ
ClinicalTrials.gov Identifier: NCT01120613     History of Changes
Other Study ID Numbers: 10-015A
Study First Received: April 29, 2010
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Nocturnal Hypertension
Nondipping
Renal Transplant
Chronotherapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014