Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2022-09-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention is a treatment algorithm (comparing two combination treatment strategies with the World Health Organization (WHO) standard and not an individual drug.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention 1: dual combination

dual combination of half-dose Calcium Channel Blocker (CCB) and Angiotensin II Receptor Blocker (ARB), dosage increases at 4 and 8 weeks if target blood pressure is not reached at the respective time point

Group Type ACTIVE_COMPARATOR

dual combination

Intervention Type OTHER

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)

Intervention 2: triple combination

triple combination of quarter-dose of Calcium Channel Blocker (CCB), Thiazide diuretic (TZD) and Angiotensin II Receptor Blocker (ARB) with dosage increases of all drugs at 4 and 8 weeks, if target blood pressure is not reached at the respective time point

Group Type ACTIVE_COMPARATOR

triple combination

Intervention Type OTHER

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)

Standard of care

start normal dose Calcium Channel Blocker (CCB), add Thiazide diuretic (TZD) after 4weeks and increase of TZD dosage after 8 weeks, if target blood pressure is not reached at the respective time point

Group Type PLACEBO_COMPARATOR

Standard of care

Intervention Type OTHER

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)

Interventions

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dual 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)

Intervention Type OTHER

triple 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)

Intervention Type OTHER

Standard 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)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No