Treatment in morning versus evening study

Not Applicable

Completed

• Conditions: Topic: Primary Care, Cardiovascular disease; Subtopic: Other Primary Care, Cardiovascular (all Subtopics); Disease: All Diseases, Other; Circulatory System

• Registration Number: ISRCTN18157641
• Lead Sponsor: HS Tayside (UK)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26861939 protocol 2018 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/29880573 substudy protocol 2017 Other publications in https://doi.org/10.1186/s13063-017-2318-4 analysis of recruitment, retention and follow-up rates (added 18/03/2020) 2022 Results article in https://doi.org/10.1016 /S0140-6736(22)01786-X (added 13/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-20
• Study Completion: 2022-07-27
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21104

Inclusion Criteria

1. Both diagnosed and treated for hypertension (all forms) with at least one antihypertensive drug
2. Aged above 18 years
3. Have a valid email address

Exclusion Criteria

1. Subjects who take twice daily antihypertensive therapy.
2. Subjects who work shift patterns that include a night shift.
3. Subjects who unwilling to consent to:
3.1. Follow up
3.2. Provide a surrogate to be contacted and/or
3.3. Give consent for their family practice to release follow up clinical data
3.4. To have their physical case records abstracted if required
3.5. To have their electronic case records searched and abstracted if required
3.6. To allow their consent from to be copied to authorities from whom the study team is requesting medical data
4. Those participating in another clinical trial or who have done in the last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Anti Platelet Trialists' Collaboration: composite endpoint of non-fatal myocardial infarction, non-fatal stroke or vascular death.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Each component of the primary endpoint<br> 2. Hospitalisation for non-fatal stroke<br> 3. Hospitalisation for non-fatal MI<br> 4. Vascular death<br> 5. All-cause mortality<br> 6. Hospitalisation or death from congestive heart failure.<br><br> 1. Adherence to the evening dosing regimen vs morning (patient reported) with particular reference to patients taking diuretic therapy.<br> 2. Patient reported and hospitalised adverse events in the morning versus evening groups will be compared. In particular falls and fractures will be recorded.<br> 3. Home BP readings taken by a subset of patients will be compared between morning & evening dosing.<br> 4. An additional proposed substudy is a telephone administered cognitive function assessment to compare patients on morning and evening dosing.<br>