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Recruitment Status : Withdrawn (primary investigator left institution; not enough patients)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

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Chronotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study
Study Start Date : April 2010
Estimated Primary Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Percent drop in mean SBP at night time compared to mean SBP at day time [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Urine Microalbumin to creatinine ratio [ Time Frame: 2 months ]
  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01120613

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


Responsible Party: Rajiv Vij MD MPH, North Shore LIJ Identifier: NCT01120613     History of Changes
Other Study ID Numbers: 10-015A
First Posted: May 11, 2010    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

Keywords provided by Northwell Health:
Nocturnal Hypertension
Renal Transplant

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases