Clinical trial NCT01669928: Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control
Official title: Hellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
First posted: 2012-08-21
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomised crossover trial of anti-hypertensive medication dosing regimen in effective blood pressure control.

To investigate whether there is a difference in 24 hour blood pressure (BP) control when antihypertensive medications are taken in the morning compared with the evening.

Detailed description: The identification of any significant difference could lead to more effective therapeutic management of arterial hypertension, which in turn would result in a reduced cardiovascular burden, lower costs and a better quality of life for hypertensive patients.

Eligibility criteria: Inclusion Criteria:

* Caucasian patients aged 18-80 years;
* History of any grade of hypertension for at least 1 year, including at least 3 months of constant antihypertensive medication (consisting of ≥ 1 antihypertensive drugs, each administered in one dose daily), with reasonably controlled BP (≤150/90 mmHg and ≥ 115/75 mmHg on usual medication) based on previous clinic records, in the last 3 months.

Exclusion Criteria:

* BP levels \> 150/90 mmHg or \< 115/75 mmHg in the last 3 months.
* Postural hypotension, defined as symptoms resulting from a \> 20 mm Hg drop of systolic BP or a \> 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing from the sitting position.
* Known Extreme dippers at baseline (fall of mean night time SBP \> 20% of mean day time SBP)
* Individuals with jobs which require night-time shift work.
* Pregnant women or those planning to become pregnant.

Primary outcomes:
measure: Changes in 24 Hour Systolic Blood Pressure
timeFrame: 6 months
Secondary outcomes:
measure: Mean Day-time ABPM Systolic BP
timeFrame: 6 months
measure: Mean Day-time ABPM Diastolic BP
timeFrame: 6 months
measure: Μean Night Time ABPM Systolic BP
timeFrame: 6 months
measure: Μean Night Time ABPM Diastolic BP
timeFrame: 6 months
measure: Mean Clinic - Systolic BP
timeFrame: 6 months
measure: Mean Clinic - Diastolic BP
timeFrame: 6 months
measure: Self Reported Side Effects
timeFrame: 12 months
measure: Quality of Life Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
city: London
country: United Kingdom
facility: Imperial Clinical Trials Unit
Study officials:
affiliation: Imperial College London
name: Neil Poulter, MRCS LRCP MBBS MRCP MSc FRCP
role: PRINCIPAL_INVESTIGATOR
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citation: Mayet J, Chapman N, Li CK, Shahi M, Poulter NR, Sever PS, Foale RA, Thom SA. Ethnic differences in the hypertensive heart and 24-hour blood pressure profile. Hypertension. 1998 May;31(5):1190-4. doi: 10.1161/01.hyp.31.5.1190.
citation: Poulter NR, Savopoulos C, Anjum A, Apostolopoulou M, Chapman N, Cross M, Falaschetti E, Fotiadis S, James RM, Kanellos I, Szigeti M, Thom S, Sever P, Thompson D, Hatzitolios AI. Randomized Crossover Trial of the Impact of Morning or Evening Dosing of Antihypertensive Agents on 24-Hour Ambulatory Blood Pressure. Hypertension. 2018 Oct;72(4):870-873. doi: 10.1161/HYPERTENSIONAHA.118.11101.