Blood Pressure
Conditions
Keywords
Blood pressure, Hypertension, Blacks, Africa, Blood pressure control, Side-effects
Brief summary
The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.
Detailed description
Primary objective: Sitting systolic blood pressure (average of three readings) will be the primary outcome variable. Secondary 1. To compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic; 2. To compare the duration of follow-up, during which a steady blood pressure control will be achieved; 3. To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups; 4. To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.
Interventions
DRUGamlodipine 5/10 mg per day plus valsartan 160 mg/day
Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning
DRUGhydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning
Sponsors
University of Kinshasa
Yaounde Central Hospital
University of Yaounde
University of Libreville
Institute of Cardiology Abidjan
University of Ilorin Teaching Hospital
University of Nigeria, Enugu Campus
Hospital Aristide Le Dantec, Dakar, Senegal
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Women or men within an age range from 30 to 69 years with uncomplicated hypertension. * Blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the European Societies of Hypertension and Cardiology. * Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of three readings obtained immediately after the patient has assumed a standing position). * Patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. If two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm Hg systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs. * The patient must provide informed written consent.
Exclusion criteria
* Premenopausal women not applying anticonception. * A history of cardiovascular disease. * Secondary hypertension. * Electrocardiographic left ventricular hypertrophy. * More than two cardiovascular risk factors in addition to hypertension. * Diabetes mellitus. * Renal dysfunction. * Recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks. * Severe non-cardiovascular disease. * Known contra indications for the first-line study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sitting Systolic Blood Pressure on Automated Measurement | 6 months follow-up after randomization | Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Blood Pressure Control | 6 months follow-up after randomization | The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic. |
| Side-effects to Study Medications | 6 months follow-up after randomization | — |
| Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up | 6 months follow-up after randomization | This variable gives the proportion of patients reaching blood pressure control over time (\< 140 mmHg systolic and \< 90 mmHg diastolic) |
Countries
Cameroon, Côte d’Ivoire, Gabon, Nigeria, Senegal
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amlodipine Plus Valsartan In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan. | 94 |
| Hydrochlorothiazide Plus Bisoprolol In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol | 89 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Logistical reasons | 9 | 5 |
| Overall Study | Lost to Follow-up | 9 | 10 |
| Overall Study | Moved or changed job | 6 | 13 |
| Overall Study | Side effect of medication | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Amlodipine Plus Valsartan | Hydrochlorothiazide Plus Bisoprolol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 82 Participants | 171 Participants |
| Age Continuous | 51.3 years STANDARD_DEVIATION 9.3 | 51.2 years STANDARD_DEVIATION 8.7 | 51.2 years STANDARD_DEVIATION 9 |
| Region of Enrollment Cameroon | 22 participants | 21 participants | 43 participants |
| Region of Enrollment Gabon | 6 participants | 2 participants | 8 participants |
| Region of Enrollment Nigeria | 46 participants | 46 participants | 92 participants |
| Region of Enrollment Senegal | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 53 Participants | 43 Participants | 96 Participants |
| Sex: Female, Male Male | 41 Participants | 46 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 94 | 1 / 89 |
| serious Total, serious adverse events | 0 / 94 | 0 / 89 |
Outcome results
Primary
Sitting Systolic Blood Pressure on Automated Measurement
Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.
Time frame: 6 months follow-up after randomization
Population: The main analysis included all randomised patients with at least one follow-up visit, according to the intention-to-treat principle.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amlodipine Plus Valsartan | Sitting Systolic Blood Pressure on Automated Measurement | 127.2 mmHg | Standard Deviation 10.7 |
| Hydrochlorothiazide Plus Bisoprolol | Sitting Systolic Blood Pressure on Automated Measurement | 134.1 mmHg | Standard Deviation 13.1 |
Secondary
Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up
This variable gives the proportion of patients reaching blood pressure control over time (\< 140 mmHg systolic and \< 90 mmHg diastolic)
Time frame: 6 months follow-up after randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine Plus Valsartan | Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up | 58 participants |
| Hydrochlorothiazide Plus Bisoprolol | Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up | 40 participants |
Secondary
Side-effects to Study Medications
Time frame: 6 months follow-up after randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amlodipine Plus Valsartan | Side-effects to Study Medications | 1 participants |
| Hydrochlorothiazide Plus Bisoprolol | Side-effects to Study Medications | 1 participants |
Secondary
Time to Blood Pressure Control
The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic.
Time frame: 6 months follow-up after randomization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Amlodipine Plus Valsartan | Time to Blood Pressure Control | 12 weeks |
| Hydrochlorothiazide Plus Bisoprolol | Time to Blood Pressure Control | 18 weeks |