Randomized Trial to Explore the Effect of Chronotherapy Versus Conventional BP Control to Correct Abnormal Circadian BP Pattern and Improve Allograft Function in Kidney Transplant Recipients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure Control
- Sponsor
- Mayo Clinic
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Percent drop in mean SBP at night-time compared to mean SBP in day-time
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to identify and manage factors related to blood pressure control that impact organ function and survival in kidney transplant recipients. Loss of the circadian (relating to a 24-hour rhythm) blood pressure pattern is common in kidney transplant recipients and is associated with poor allograft kidney function. It is still unclear if restoring the normal day-night blood pressure (BP) pattern will translate into better allograft outcome. Although studies in patients with and without chronic kidney disease indicate that restoration of the normal nocturnal (night) dipping in BP is possible by changing the timing of the BP medications to cover the overnight period (chronotherapy), this has not been tested in kidney transplant patients.
Detailed Description
The challenge in kidney transplantation is to identify and manage factors that impact allograft function and survival. Loss of the circadian blood pressure pattern is common in kidney transplant recipients and is associated with poor allograft kidney function. Nevertheless, it is unclear if restoring the normal day-night BP pattern will translate into better allograft outcome. Although studies in patients with and without chronic kidney disease indicate that restoration of the normal nocturnal dipping in BP is possible by changing the timing of the BP medications to cover the overnight period (chronotherapy), this has not been tested in kidney transplant patients. This exploratory study is driven by the hypothesis that chronotherapy will restore the normal circadian BP pattern and will translate into better allograft function and into lower LVM 1-year from transplantation.
Investigators
Hani M. Wadei
Cons-Nephrology
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Recipient of a kidney transplant.
- •Age≥18 years.
- •Stable allograft function.
- •Ability to give informed consent.
Exclusion Criteria
- •Multiorgan transplant recipients.
- •Kidney transplant recipients with poor allograft function.
- •Documented history of obstructive sleep apnea.
Outcomes
Primary Outcomes
Percent drop in mean SBP at night-time compared to mean SBP in day-time
Time Frame: 1 year
Glomerular filtration rate
Time Frame: 1 year
Secondary Outcomes
- Awake mean SBP(1 year)
- Presence of abnormal circadian BP pattern in recipients on steroid free and CIN free IS(1 year)
- Change in LVM(1 year)
- Urinary microalbumin excretion(4 months & 1 year)
- Long term renal function(2 years)
- Cardiovascular events (stroke, heart failure, myocardial infarction)(2 years)