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Post Kidney Transplant Nocturnal Hypertension Prevalence and Management Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by North Shore Long Island Jewish Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01120613
First received: April 29, 2010
Last updated: May 7, 2010
Last verified: May 2010
History of Changes

April 29, 2010
May 7, 2010
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01120613 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
85
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
Both
18 Years to 70 Years
No
Contact: Rajiv Vij, MD MPH 516-465-8200 rvij@nshs.edu
Contact: Kenar Jhaveri, MD 516-465-8200 kjhaveri@nshs.edu
United States
 
NCT01120613
10-015A
No
Rajiv Vij MD MPH, North Shore LIJ
North Shore Long Island Jewish Health System
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
North Shore Long Island Jewish Health System
May 2010

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