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

Not Applicable

Completed

• Conditions: Blood Pressure Control; Kidney Transplant Recipient
• Interventions: Other: Medication Adjustment

• Registration Number: NCT01093703
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-26
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Recipient of a kidney transplant.
• Age≥18 years.
• Stable allograft function.
• Ability to give informed consent.

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Exclusion Criteria

• Multiorgan transplant recipients.
• Kidney transplant recipients with poor allograft function.
• Documented history of obstructive sleep apnea.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intensive Therapy	Medication Adjustment	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.

Primary Outcome Measures

Name	Time	Method
Percent drop in mean SBP at night-time compared to mean SBP in day-time	1 year
Glomerular filtration rate	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States