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

Not Applicable

Completed

• Conditions: Arterial Hypertension
• Interventions: Other: Standard of care; Other: dual combination; Other: triple combination

• Registration Number: NCT04129840
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-15
• Study First Posted: 2019-10-17
• Study Start: 2020-03-05
• Primary Completion: 2022-09-22
• Study Completion: 2022-09-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	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
Intervention 1: dual combination	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
Intervention 2: triple combination	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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 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
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)
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 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 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)
Cost-effectiveness of the 3 treatment algorithms	within 24 weeks after enrolment	Cost-effectiveness of the 3 treatment algorithms
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)
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
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 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
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)
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
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 at least one severe adverse event	within 24 weeks after enrolment	Proportion of patients with at least one severe adverse event

Trial Locations

Locations (3)

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