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

University Hospital Basel

Status: Completed

Conditions: Arterial Hypertension

Treatments: Other: triple combination; Other: dual combination; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT04129840

2019-00817 qu19Weisser;

Details and patient eligibility

About

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.

Enrollment: 1,268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,268 participants in 3 patient groups, including a placebo group

Intervention 1: dual combination

Active Comparator group

Description:

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

Treatment:

Other: dual combination

Intervention 2: triple combination

Active Comparator group

Description:

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

Treatment:

Other: triple combination

Standard of care

Placebo Comparator group

Description:

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

Treatment:

Other: Standard of care