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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
1,268
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)
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)
SolidarMed Lesotho, Mokhotlong Government Hospital
Mokhotlong, Lesotho
Division of Infectious Diseases & Hospital Epidemiology; University Hospital Basel
Basel, Switzerland
St. Francis Referral Hospital/ Ifakara Health Institute
Ifakara, Morogoro, Tanzania
Proportion of patients reaching a target blood pressure
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
Time frame: at 12 weeks after enrolment
Proportion of patients reaching a target blood pressure
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
Time frame: at 4, 8 and 24 weeks after enrolment
Change in blood pressure (mmHg)
Change in blood pressure (change from enrolment) (mmHg)
Time frame: at 4, 8, 12, 24 weeks after enrolment
Proportion of patients with treatment adaptations made to the primary treatment
Proportion of patients with treatment adaptations made to the primary treatment (dose increases and/or drug additions)
Time frame: within 12 weeks after enrolment
Number of treatment adaptations per patient made to the primary treatment
Number of treatment adaptations per patient made to the primary treatment
Time frame: within 12 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
Time until first target blood pressure of \</=130/80 mmHg in patients \<65years of age and \</=140/90mmHg in patients \>65years of age
Time frame: within 24 weeks after enrolment
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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)
Proportion of patients with major cardiovascular endpoints
Proportion of patients with major cardiovascular endpoints such as death, stroke, myocardial infarction, heart failure)
Time frame: within 24 weeks after enrolment
Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage
Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage (resolving, newly occurring or worsening)
Time frame: within 24 weeks after enrolment
Proportion of patients lost to follow up or stopped treatment
Proportion of patients lost to follow up or stopped treatment
Time frame: within 24 weeks after enrolment
Proportion of patients with at least one grade 3/4 adverse event
Proportion of patients with at least one grade 3/4 adverse event
Time frame: within 24 weeks after enrolment
Proportion of patients with at least one severe adverse event
Proportion of patients with at least one severe adverse event
Time frame: within 24 weeks after enrolment
Proportion of patients who were non-adherent to drugs
Proportion of patients who were non-adherent to drugs (\<90% pill count or \<90% of self-reported drug intake)
Time frame: at 12 weeks after enrolment
Reasons for non-adherence assessed by pill count (descriptive analysis)
Reasons for non-adherence assessed by pill count (descriptive analysis)
Time frame: within 24 weeks after enrolment
Cost-effectiveness of the 3 treatment algorithms
Cost-effectiveness of the 3 treatment algorithms
Time frame: within 24 weeks after enrolment
Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement
Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement
Time frame: 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)
Proportion of patients with blood pressure control determined by 24h ambulatory blood pressure measurement (24h mean blood pressure \<130/80mmHg irrespective of age)
Time frame: within 12 weeks after enrolment
Reasons for non-adherence assessed by self-report (descriptive analysis)
Reasons for non-adherence assessed by self-report (descriptive analysis)
Time frame: within 24 weeks after enrolment