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.
|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|
- Percent drop in mean SBP at night time compared to mean SBP at day time [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- 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.
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Patients identified with Nocturnal Hypertension, will have one of the blood pressure medications switched from daytime dosing to nighttime dosing
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:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120613
|United States, New York|
|North Shore Long Island Jewish Hospital|
|Great Neck, New York, United States, 11020|
|Principal Investigator:||Rajiv Vij, MD MPH||North Shore Long Island Jewish Hospital|
|Principal Investigator:||Kenar Jhaveri, MD||North Shore Long Island Jewish Hospital|