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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hani M. Wadei, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01093703
First received: March 24, 2010
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Blood Pressure Control
Kidney Transplant Recipient
Other: Medication Adjustment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Percent drop in mean SBP at night-time compared to mean SBP in day-time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Glomerular filtration rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Awake mean SBP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Presence of abnormal circadian BP pattern in recipients on steroid free and CIN free IS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in LVM [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Urinary microalbumin excretion [ Time Frame: 4 months & 1 year ] [ Designated as safety issue: No ]
  • Long term renal function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cardiovascular events (stroke, heart failure, myocardial infarction) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: December 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional Therapy
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.
Active Comparator: Intensive Therapy
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093703

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
  More Information

Additional Information:
Publications:

Responsible Party: Hani M. Wadei, Cons-Nephrology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01093703     History of Changes
Other Study ID Numbers: 08-005049
Study First Received: March 24, 2010
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
kidney transplantation
hypertension
chronotherapy
graft function
circadian pattern

ClinicalTrials.gov processed this record on August 28, 2014