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Completed

NCT Number: NCT01093703

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medication Adjustment

Other
  • Awake SBP≤135/85mmHg and patient is on once daily medications: Switch BP medications to pm period.
  • 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.
  • Awake SBP≤135/85mmHg and patient is not on anti-hypertensive medications: Add BP medication at the pm period.
  • Awake SBP>135/85mmHg: increase dose of antihypertensive medications or add more medications. All medications to be given in the evening time.

Primary outcomes

  1. Percent drop in mean SBP at night-time compared to mean SBP in day-time

    Time frame: 1 year

  2. Glomerular filtration rate

    Time frame: 1 year

Secondary outcomes

  1. Awake mean SBP

    Time frame: 1 year

  2. Presence of abnormal circadian BP pattern in recipients on steroid free and CIN free IS

    Time frame: 1 year

  3. Change in LVM

    Time frame: 1 year

  4. Urinary microalbumin excretion

    Time frame: 4 months & 1 year

  5. Long term renal function

    Time frame: 2 years

  6. Cardiovascular events (stroke, heart failure, myocardial infarction)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2010
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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