Arterial Hypertension
Conditions
Keywords
antihypertensive treatment
Brief summary
This study is to compare the effectiveness of three different antihypertensive treatment strategies for reaching a target blood pressure (clinic BP) of \</= 130/80 mmHg among patients \<65years of age and \</= 140/90 mmHg among patients \>/=65years of Age in HIV-positive and HIV-negative patients with uncomplicated arterial hypertension in rural Tanzania and Lesotho.
Interventions
OTHERdual combination
Participants will be started on a dual therapy with half dose of CCB and an ARB. If needed, a) the dose of the CCB will be increased at 4 weeks, and b) the dose of the ARB at 8 weeks, if blood pressure remains uncontrolled ((if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP \</=130/80mmHg in patients \<65years and \</=140/90mmHg in patients \>65years)
OTHERtriple combination
Participants will be started with low dose (1/4) triple combination treatment with CCB, TZD and ARB. If uncontrolled after 4 weeks, dosages of all drugs will be doubled. If after 8 weeks still uncontrolled dosage will be increased to full dose of all three drugs ((if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP \</=130/80mmHg in patients \<65years and \</=140/90mmHg in patients \>65years)
OTHERStandard of care
Participants will be started on regular dose of CCB with a) addition of TZD at 4 weeks, if needed, b) increase of dose of TZD after 8 weeks, if needed (if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP \</=130/80mmHg in patients \<65years and \</=140/90mmHg in patients \>65years)
Sponsors
Swiss National Fund for Scientific Research
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
The intervention is a treatment algorithm (comparing two combination treatment strategies with the World Health Organization (WHO) standard and not an individual drug.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-positive and negative patients of African descent and black ethnicity with a documented uncomplicated, untreated arterial hypertension (blood pressure \>/=140/90 mmHg) diagnosed at one of the 2 study sites
Exclusion criteria
* Current hospitalization for any reason * Not of African descent * Refusal of an HIV-test or indeterminate HIV test result * History of cardiovascular event in the last month (anginal pain, stroke, myocardial infarction or diagnosis by a doctor) * Symptomatic arterial hypertension (blood pressure \>/=180/110 mmHg plus headache or chest pain) or acute cardiovascular event * acute disease, (e.g. fever \>37.5°C or other signs of acute concomitant infection; Dyspnea/respiratory distress; Acute pain) * Clinical signs of hypertension-mediated organ damage (heart failure, bilateral pitting edema, bilateral crackles or pleural effusion, distended jugular veins, ischemic heart disease (anginal pain on exertion), signs of current ischemic/hemorrhagic stroke (hemiparesis, loss of consciousness) * Pregnancy (test required for females 18-45years of age) * Non-consenting or inability to come for follow-up visits * creatinine clearance \</=30ml/min by Chronic Kidney Disease Epidemiology Formula (CK-EPI) estimation and measurement with a point-of care creatinine from capillary blood
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients reaching a target blood pressure | at 12 weeks after enrolment | Proportion of patients reaching a target blood pressure (clinic blood pressure) of \</=130/80 mmHg in patients \<65years of age and \</=140/90 mmHg in patients \>65years of age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with at least one severe adverse event | within 24 weeks after enrolment | Proportion of patients with at least one severe adverse event |
| Proportion of patients with at least one grade 3/4 adverse event | within 24 weeks after enrolment | Proportion of patients with at least one grade 3/4 adverse event |
| Proportion of patients reaching a target blood pressure | at 4, 8 and 24 weeks after enrolment | Proportion of patients reaching a target blood pressure (clinic blood pressure) of \</=130/80mmHg in patients \<65years of age and \</=140/90mmHg in patients \>65years of age |
| Change in blood pressure (mmHg) | at 4, 8, 12, 24 weeks after enrolment | Change in blood pressure (change from enrolment) (mmHg) |
| Proportion of patients with treatment adaptations made to the primary treatment | within 12 weeks after enrolment | Proportion of patients with treatment adaptations made to the primary treatment (dose increases and/or drug additions) |
| Number of treatment adaptations per patient made to the primary treatment | within 12 weeks after enrolment | Number of treatment adaptations per patient made to the primary treatment |
| Time until first target blood pressure of </=130/80 mmHg in patients <65years of age and </=140/90mmHg in patients >65years of age | within 24 weeks after enrolment | Time until first target blood pressure of \</=130/80 mmHg in patients \<65years of age and \</=140/90mmHg in patients \>65years of age |
| Proportion of patients with major cardiovascular endpoints | within 24 weeks after enrolment | Proportion of patients with major cardiovascular endpoints such as death, stroke, myocardial infarction, heart failure) |
| Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage | within 24 weeks after enrolment | Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage (resolving, newly occurring or worsening) |
| Proportion of patients lost to follow up or stopped treatment | within 24 weeks after enrolment | Proportion of patients lost to follow up or stopped treatment |
| Proportion of patients who were non-adherent to drugs | at 12 weeks after enrolment | Proportion of patients who were non-adherent to drugs (\<90% pill count or \<90% of self-reported drug intake) |
| Reasons for non-adherence assessed by pill count (descriptive analysis) | within 24 weeks after enrolment | Reasons for non-adherence assessed by pill count (descriptive analysis) |
| Cost-effectiveness of the 3 treatment algorithms | within 24 weeks after enrolment | Cost-effectiveness of the 3 treatment algorithms |
| Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement | within 12 weeks after enrolment | Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement |
| Proportion of patients with blood pressure control determined by 24h ambulatory blood pressure measurement (24h mean blood pressure <130/80mmHg irrespective of age) | within 12 weeks after enrolment | Proportion of patients with blood pressure control determined by 24h ambulatory blood pressure measurement (24h mean blood pressure \<130/80mmHg irrespective of age) |
| Reasons for non-adherence assessed by self-report (descriptive analysis) | within 24 weeks after enrolment | Reasons for non-adherence assessed by self-report (descriptive analysis) |
Countries
Lesotho, Switzerland, Tanzania
Outcome results
None listed