Hypertension
Conditions
Keywords
Hypertension
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.
Interventions
DRUGAnti-hypertensive Medication -
Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication. Dosing regimen either in the morning (between 06.00 and 11.00) or in the evening (between 18.00 and 23.00).
Sponsors
Aristotle University Of Thessaloniki
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in 24 Hour Systolic Blood Pressure | 6 months | Changes in 24 hour systolic Blood Pressure using ABPM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Day-time ABPM Diastolic BP | 6 months | — |
| Μean Night Time ABPM Systolic BP | 6 months | — |
| Μean Night Time ABPM Diastolic BP | 6 months | — |
| Mean Day-time ABPM Systolic BP | 6 months | — |
| Mean Clinic - Diastolic BP | 6 months | This measure was assessed at a clinic. |
| Self Reported Side Effects | 12 months | Serious Adverse Events reported during the trial |
| Quality of Life Score | 6 months | Quality of Life Score via questionnaire - EQ-5D-5L Score scale is 0-100, 100 optimal health state. |
| Mean Clinic - Systolic BP | 6 months | This measure was assessed at a clinic. |
Countries
Greece, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Morning Medication, Then Evening Antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months, then cross over to antihypertensive medication in the evening (between 18.00 and 23.00) for 6 months.
Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication. | 51 |
| Evening Medication, Then Morning Anti hypertensive medication in the evening (between 18.00 and 23.00) for 6 months, then cross over to antihypertensive medication in the morning (between 06.00 and 11.00) for 6 months,
Anti-hypertensive Medication -: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication. | 52 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Evening Medication, Then Morning | Total | Morning Medication, Then Evening |
|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 9.7 | 61.8 years STANDARD_DEVIATION 10.3 | 61.8 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 103 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Greece | 25 participants | 50 participants | 25 participants |
| Region of Enrollment United Kingdom | 27 participants | 53 participants | 26 participants |
| Sex: Female, Male Female | 21 Participants | 45 Participants | 24 Participants |
| Sex: Female, Male Male | 31 Participants | 58 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 95 | 0 / 97 |
| other Total, other adverse events | 0 / 97 | 0 / 95 |
| serious Total, serious adverse events | 0 / 95 | 3 / 97 |
Outcome results
Primary
Changes in 24 Hour Systolic Blood Pressure
Changes in 24 hour systolic Blood Pressure using ABPM
Time frame: 6 months
Population: Total of 8 withdrawals / drop outs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning Medication | Changes in 24 Hour Systolic Blood Pressure | 129.65 mm Hg | Standard Deviation 10.66 |
| Evening Medication | Changes in 24 Hour Systolic Blood Pressure | 129.75 mm Hg | Standard Deviation 12.75 |
Secondary
Mean Clinic - Diastolic BP
This measure was assessed at a clinic.
Time frame: 6 months
Population: Total of 8 withdrawals / drop outs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning Medication | Mean Clinic - Diastolic BP | 77.26 mm Hg | Standard Deviation 7.12 |
| Evening Medication | Mean Clinic - Diastolic BP | 77.41 mm Hg | Standard Deviation 8.36 |
Secondary
Mean Clinic - Systolic BP
This measure was assessed at a clinic.
Time frame: 6 months
Population: Total of 8 withdrawals / drop outs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning Medication | Mean Clinic - Systolic BP | 129.37 mm Hg | Standard Deviation 11.21 |
| Evening Medication | Mean Clinic - Systolic BP | 129.81 mm Hg | Standard Deviation 12.53 |
Secondary
Mean Day-time ABPM Diastolic BP
Time frame: 6 months
Population: Total of 8 withdrawals / drop outs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning Medication | Mean Day-time ABPM Diastolic BP | 79.27 mm Hg | Standard Deviation 7.73 |
| Evening Medication | Mean Day-time ABPM Diastolic BP | 80.55 mm Hg | Standard Deviation 8.51 |
Secondary
Mean Day-time ABPM Systolic BP
Time frame: 6 months
Population: Total of 8 withdrawals / drop outs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning Medication | Mean Day-time ABPM Systolic BP | 132.24 mm Hg | Standard Deviation 10.86 |
| Evening Medication | Mean Day-time ABPM Systolic BP | 132.77 mm Hg | Standard Deviation 12.87 |
Secondary
Quality of Life Score
Quality of Life Score via questionnaire - EQ-5D-5L Score scale is 0-100, 100 optimal health state.
Time frame: 6 months
Population: Total of 8 withdrawals / drop outs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning Medication | Quality of Life Score | 84.14 Score out of 100 | Standard Deviation 11.45 |
| Evening Medication | Quality of Life Score | 84.04 Score out of 100 | Standard Deviation 10.25 |
Secondary
Self Reported Side Effects
Serious Adverse Events reported during the trial
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Morning Medication | Self Reported Side Effects | 0 Serious Adverse Events |
| Evening Medication | Self Reported Side Effects | 3 Serious Adverse Events |
Secondary
Μean Night Time ABPM Diastolic BP
Time frame: 6 months
Population: Total of 8 withdrawals / drop outs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning Medication | Μean Night Time ABPM Diastolic BP | 70.92 mm Hg | Standard Deviation 9.68 |
| Evening Medication | Μean Night Time ABPM Diastolic BP | 70.57 mm Hg | Standard Deviation 9.67 |
Secondary
Μean Night Time ABPM Systolic BP
Time frame: 6 months
Population: Total of 8 withdrawals / drop outs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Morning Medication | Μean Night Time ABPM Systolic BP | 122.76 mm Hg | Standard Error 12.18 |
| Evening Medication | Μean Night Time ABPM Systolic BP | 121.08 mm Hg | Standard Error 14.92 |