Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01120613
Recruitment Status : Withdrawn (primary investigator left institution; not enough patients)
First Posted : May 11, 2010
Last Update Posted : May 30, 2013
Information provided by:
Northwell Health

April 29, 2010
May 11, 2010
May 30, 2013
April 2010
August 2010   (Final data collection date for primary outcome measure)
Percent drop in mean SBP at night time compared to mean SBP at day time [ Time Frame: 2 months ]
Same as current
Complete list of historical versions of study NCT01120613 on Archive Site
  • Urine Microalbumin to creatinine ratio [ Time Frame: 2 months ]
  • Change in Glomerular filtration rate as measured by MDRD equation. [ Time Frame: 2 months ]
    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 ]
    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.
Same as current
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Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study
Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study
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.
Not Provided
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Experimental: chronotherapy
Patients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing
Intervention: Drug: Chronotherapy

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Rajiv Vij MD MPH, North Shore LIJ
Northwell Health
Not Provided
Principal Investigator: Rajiv Vij, MD MPH North Shore Long Island Jewish Hospital
Principal Investigator: Kenar Jhaveri, MD North Shore Long Island Jewish Hospital
Northwell Health
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP