Summary of the ongoing trials examining effect of night-time BP lowering drugs on CVD
| Study characteristics | TIME (UK) [17] | BPMedtime (US) [18] | Bedmed (Canada) [19] | Bedmed-frail (Canada) |
|---|---|---|---|---|
| Study design | PROBE (“All endpoint adjudication will be blinded to dosing time”) | Unclear | PROBE (primary and secondary outcomes: “will be reviewed by a panel of three physicians blinded to allocation”) | PROBE |
| Population | Hypertensive patients using antihypertensives | Hypertensive patients with > 1 other significant increased CVD risks in university health care systems | Hypertensive patients in primary care using antihypertensives and free from glaucoma | Hypertensive patients in long term care facilities using antihypertensives and free from glaucoma |
| Intervention | Evening use of all antihypertensives (20:00–midnight) | Night-time use of all once-daily non-diuretic antihypertensives | Bedtime use of all antihypertensives | |
| Comparator | Morning use of all antihypertensives (6:00–10:00) | Morning use of all antihypertensives | Morning use of all antihypertensives | |
| Main outcomes | Composite of CVD death or hospitalisation for CVD | Composite of CVD death or hospitalisation for CVD | Composite of all-cause death or hospitalisation for CVD | |
| Follow-up | 4 years | 36–42 months | 3 years | 2 years |
| Sample size | Estimated 10,269 participants (randomised 21,104 participants) | 1,000 | 254 main outcome events as in MAPEC (recruited 3,357 participants) | 368 main outcome events (estimated 775 participants) |
| Recruitment duration | 8/2011–7/2016 | No information | 12/2016–6/2022 | 5/2020–ongoing |
| Study duration | 8/2011–6/2022 | 2013–2015 (stopped at pilot phase) | 12/2016–12/2023 | 5/2020–10/2023 |
| Trial registration | ISRCTN18157641 (https://www.isrctn.com/ISRCTN18157641) | No information | ClinicalTrials.gov Identifier: NCT02990663 | ClinicalTrials.gov Identifier: NCT04054648 |
