CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 enrolled
Drug / intervention
Medication Adjustmentother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01093703
NCT01093703N/ACompleted

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

Mayo Clinic·interventional·Posted Mar 26, 2010·Updated May 30, 2013

In Brief

A clinical study evaluating Medication Adjustment for Blood Pressure Control and Kidney Transplant Recipient. Completed, enrolled 99 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2010
Enrollment StartDec 1, 2008
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 16.3 years ago

Interventions

Medication Adjustmentother

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.