Blood Pressure Control, Kidney Transplant Recipient
Conditions
Keywords
kidney transplantation, hypertension, chronotherapy, graft function, circadian pattern
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.
Interventions
OTHERMedication Adjustment
1. Awake SBP≤135/85mmHg and patient is on once daily medications: Switch BP medications to pm period. 2. Awake SBP SBP≤135/85mmHg and patient is on bid medications (e.g. metoprolol bid): Increase pm dose of the medication. If medication is already is at maximal dose or there is contraindication for increasing the dose (e.g. bradycardia), add another BP medicine in the evening time. 3. Awake SBP≤135/85mmHg and patient is not on anti-hypertensive medications: Add BP medication at the pm period. 4. Awake SBP\>135/85mmHg: increase dose of antihypertensive medications or add more medications. All medications to be given in the evening time.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent drop in mean SBP at night-time compared to mean SBP in day-time | 1 year |
| Glomerular filtration rate | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed