NCT01093703

Chronotherapy Versus Conventional BP Control to Correct Abnormal Circadian BP Pattern in Kidney Transplant Recipients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Pressure Control
• Kidney Transplant Recipient

Interventions

Type	Name	Description
OTHER	Medication 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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-03-26
• Last updated: 2013-05-30

Locations

1 site across 1 country: United States