Clinical trial NCT04129840: Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa
Official title: Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Hypertension
Keywords: antihypertensive treatment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Fund for Scientific Research
First posted: 2019-10-17
Enrollment: 1268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients reaching a target blood pressure
timeFrame: at 12 weeks after enrolment
Secondary outcomes:
measure: Proportion of patients reaching a target blood pressure
timeFrame: at 4, 8 and 24 weeks after enrolment
measure: Change in blood pressure (mmHg)
timeFrame: at 4, 8, 12, 24 weeks after enrolment
measure: Proportion of patients with treatment adaptations made to the primary treatment
timeFrame: within 12 weeks after enrolment
measure: Number of treatment adaptations per patient made to the primary treatment
timeFrame: within 12 weeks after enrolment
measure: Time until first target blood pressure of </=130/80 mmHg in patients <65years of age and </=140/90mmHg in patients >65years of age
timeFrame: within 24 weeks after enrolment
measure: Proportion of patients with major cardiovascular endpoints
timeFrame: within 24 weeks after enrolment
measure: Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage
timeFrame: within 24 weeks after enrolment
measure: Proportion of patients lost to follow up or stopped treatment
timeFrame: within 24 weeks after enrolment
measure: Proportion of patients with at least one grade 3/4 adverse event
timeFrame: within 24 weeks after enrolment
measure: Proportion of patients with at least one severe adverse event
timeFrame: within 24 weeks after enrolment
measure: Proportion of patients who were non-adherent to drugs
timeFrame: at 12 weeks after enrolment
measure: Reasons for non-adherence assessed by pill count (descriptive analysis)
timeFrame: within 24 weeks after enrolment
measure: Cost-effectiveness of the 3 treatment algorithms
timeFrame: within 24 weeks after enrolment
measure: Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement
timeFrame: within 12 weeks after enrolment
measure: Proportion of patients with blood pressure control determined by 24h ambulatory blood pressure measurement (24h mean blood pressure <130/80mmHg irrespective of age)
timeFrame: within 12 weeks after enrolment
measure: Reasons for non-adherence assessed by self-report (descriptive analysis)
timeFrame: within 24 weeks after enrolment
Other outcomes:
Locations:
city: Mokhotlong
country: Lesotho
facility: SolidarMed Lesotho, Mokhotlong Government Hospital
city: Basel
country: Switzerland
facility: Division of Infectious Diseases & Hospital Epidemiology; University Hospital Basel
city: Ifakara
country: Tanzania
facility: St. Francis Referral Hospital/ Ifakara Health Institute
state: Morogoro
Study officials:
affiliation: Division of Infectious Diseases & Hospital Epidemiology, University Hospital Basel
name: Maja Weisser Rohacek, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mapesi H, Gupta R, Wilson HI, Lukau B, Amstutz A, Lyimo A, Muhairwe J, Senkoro E, Byakuzana T, Mphunyane M, Bresser M, Glass TR, Lambiris M, Fink G, Gingo W, Battegay M, Paris DH, Rohacek M, Vanobberghen F, Labhardt ND, Burkard T, Weisser M. The coArtHA trial-identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial. Trials. 2021 Jan 21;22(1):77. doi: 10.1186/s13063-021-05023-z.