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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Therapy | No Intervention | In the conventional therapy group, no medication changes other than the ones needed to achieve target awake average SBP will be undertaken. Time at which patients are taking their BP medications will be recorded. | |
| Intensive Therapy | Active Comparator | In the intensive therapy group, BP medications will be adjusted to both control awake average systolic BP to target and to cover the overnight period in an attempt to control nocturnal hypertension. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Adjustment | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent drop in mean SBP at night-time compared to mean SBP in day-time | 1 year | |
| Glomerular filtration rate | 1 year |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10665703 | Background | Mange KC, Cizman B, Joffe M, Feldman HI. Arterial hypertension and renal allograft survival. JAMA. 2000 Feb 2;283(5):633-8. doi: 10.1001/jama.283.5.633. | |
| 15168388 | Background | Kasiske BL, Anjum S, Shah R, Skogen J, Kandaswamy C, Danielson B, O'Shaughnessy EA, Dahl DC, Silkensen JR, Sahadevan M, Snyder JJ. Hypertension after kidney transplantation. Am J Kidney Dis. 2004 Jun;43(6):1071-81. doi: 10.1053/j.ajkd.2004.03.013. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 1 year |
| Urinary microalbumin excretion | 4 months & 1 year |
| Long term renal function | 2 years |
| Cardiovascular events (stroke, heart failure, myocardial infarction) | 2 years |
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