CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 776 enrolled
Drug / intervention
Bedtime administration of the participant's pre-existing antihypertensive medicationsother
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/NCT04054648
NCT04054648N/ACompleted

Does the Potential Benefit of Bedtime Antihypertensive Prescribing Extend to Frail Populations? The "BedMed-Frail" Randomized Controlled Trial

University of Alberta·interventional·Posted Aug 13, 2019·Updated Aug 27, 2024

In Brief

A clinical study evaluating Bedtime administration of the participant's pre-existing antihypertensive medications for Hypertension and Dementia. Completed, enrolled 776 participants across 1 site.

Detailed Summary

High blood pressure (present in 1 of 5 Canadian adults) increases the risk of heart attack and stroke. Blood pressure lowering pills reduce this risk - but perhaps not optimally. A Spanish study suggests that using blood pressure pills at bedtime, instead of in the morning (when they are most commonly used), reduces death, heart attack, and stroke by more than 50%. If true, a switch to bedtime prescribing would have more impact on the health of those with high blood pressure than whether high blood pressure is treated at all. BedMed, a community-based Canadian primary care trial, is already running and looking both to validate the findings of this Spanish study and to determine whether there might be unrecognized harms of bedtime use (such as more falls and fractures as a result of lower overnight blood pressure). One very important population that is likely to be more sensitive to the effects of medications, and almost always excluded from randomized trials, are the frail elderly (such as those who are resident in nursing homes). In order to have the greatest information about the safety and effectiveness of bedtime blood pressure medications, the BedMed team is additionally conducting a similar trial to BedMed in nursing homes ("BedMed-Frail" - the subject of this trial registration) to determine whether the risks and benefits of bedtime prescribing differ in this highly understudied population. Basics of the trial: When patients are admitted to nursing homes, neither they nor their physicians are consulted about the timing of blood pressure medication. Unless explicitly stated to be otherwise, blood pressure pills are instead largely arbitrarily assigned for morning use by default. Given there is evidence that bedtime administration may be safer, the nursing homes participating in BedMed-Frail will have each hypertensive resident randomized to either continue with morning blood pressure medication use, as is their norm, or to have their facility's pharmacist gradually switch each residents blood pressure pills to bedtime. Over a period of roughly 3 years, health outcomes in these facilities will be tracked using routinely collected electronic health data to determine differences in things like hospitalization, death, or hip fractures - and at the end of the study the investigators hope to determine whether or not the recommendations for blood pressure medication timing in frail older adults should differ from those for the general population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 13, 2019
Enrollment StartMay 25, 2020
Primary CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.9 years ago

Interventions

Bedtime administration of the participant's pre-existing antihypertensive medicationsother

Changing the administration time of once daily blood pressure lowering medications, one at a time as tolerated, from morning to bedtime.