Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial.

INTRODUCTION: Sleep-time blood pressure correlates more strongly with adverse cardiovascular events than does daytime blood pressure. The BedMed trial evaluates whether bedtime antihypertensive administration, as compared with conventional morning use, reduces major adverse cardiovascular events. METHODS AND ANALYSIS: DesignProspective randomised, open-label, blinded end-point trial.ParticipantsHypertensive primary care patients using blood pressure lowering medication and free from glaucoma.SettingCommunity primary care providers in 5 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba and Ontario) are mailing invitations to their eligible patients. Social media campaigns (Google, Facebook) are additionally running in the same provinces.InterventionConsenting participants are allocated via central randomisation to bedtime vs morning use of all antihypertensives.Follow-up(1) Telephone or email questionnaire at 1 week, 6 weeks, 6 months and every 6 months thereafter, and (2) accessing linked governmental healthcare databases tracking hospital and community medical services.Primary outcomeComposite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure.Secondary outcomesEach primary outcome element on its own, all-cause hospitalisation or emergency department visit, long-term care admission, non-vertebral fracture, new glaucoma diagnosis, 18-month cognitive decline from baseline (via Short Blessed Test).Select other outcomesSelf-reported nocturia burden at 6 weeks and 6 months (no, minor or major burden), 1-year self-reported overall health score (EQ-5D-5L), self-reported falls, total cost of care (acute and community over study duration) and mean sleep-time systolic blood pressure after 6 months (via 24-hour monitor in a subset of 302 sequential participants).Primary outcome analysisCox proportional hazards survival analysis.Sample sizeThe trial will continue until a projected 254 primary outcome events have occurred.Current statusEnrolment ongoing (3227 randomised to date). ETHICS AND DISSEMINATION: BedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02990663.

Case Report: Steroid-induced Ocular Hypertension in a 6-year-old Boy.

SIGNIFICANCE: Systemic corticosteroid use in children is rare because of known risks of adverse effects. The increased prevalence of multisystem inflammatory syndrome associated with COVID-19 may change this. It is critical for eye care providers to be aware of potential severe and rapid ocular hypertensive response to prevent irreversible vision loss. PURPOSE: The purpose of this study was to report the importance of early monitoring of intraocular eye pressure in pediatric patients on systemic steroid medication. CASE REPORT: A 6-year-old White boy presented with a complaint of headache for 2 weeks. He was on his 19th day of treatment for acute lymphoblastic leukemia with oral dexamethasone and chemotherapy. IOP at presentation was 65 mmHg in both eyes measured with iCare tonometry. Treatment with maximum topical glaucoma therapy reduced IOP to normal levels and eliminated the symptom of headache. CONCLUSIONS: This case reminds eye care providers to be aware of the potential ocular hypertensive response to systemic steroid treatment and the importance of establishing early monitoring. With the emergence of multisystem inflammatory syndrome in children during the current COVID-19 pandemic, eye care providers may encounter more pediatric patients on systemic corticosteroid treatment than previously and should adjust their examinations appropriately.