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

NCT04129840 | Completed

• 1 other identifier: 2019-00817; qu19Weisser
• Study Type: interventional
• Target: 1,268
• Locations: 3 countries
• Sites: 3

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.

Conditions

Arterial Hypertension

Keywords

antihypertensive treatment

Outcome Measures

Primary Outcomes (1)

• 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

  at 12 weeks after enrolment

Secondary Outcomes (16)

• Proportion of patients reaching a target blood pressure

  at 4, 8 and 24 weeks after enrolment

• Change in blood pressure (mmHg)

  at 4, 8, 12, 24 weeks after enrolment

• Proportion of patients with treatment adaptations made to the primary treatment

  within 12 weeks after enrolment

• Number of treatment adaptations per patient made to the primary treatment

  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

  within 24 weeks after enrolment

Study Arms (3)

Intervention 1: dual combination

ACTIVE COMPARATOR

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

Other: dual combination

Intervention 2: triple combination

ACTIVE COMPARATOR

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

Other: triple combination

Standard of care

PLACEBO COMPARATOR

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

Other: Standard of care

Interventions

dual combination 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 1: dual combination

triple combination 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)

Intervention 2: triple combination

Standard of care 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)

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Fund for Scientific Research: collaborator

Study Sites (3)

SolidarMed Lesotho, Mokhotlong Government Hospital

Mokhotlong, Lesotho

Location

Division of Infectious Diseases & Hospital Epidemiology; University Hospital Basel

Basel, 4031, Switzerland

Location

St. Francis Referral Hospital/ Ifakara Health Institute

Ifakara, Morogoro, Tanzania

Location

Related Publications (2)

• Mapesi H, Rohacek M, Vanobberghen F, Gupta R, Wilson HI, Lukau B, Amstutz A, Lyimo A, Muhairwe J, Senkoro E, Byakuzana T, Nkouabi J, Mbunda G, Siru J, Tarr A, Ramapepe E, Mphunyane M, Oehri J, Nemtsova V, Yan X, Bresser M, Glass TR, Paris DH, Fink G, Gingo W, Labhardt ND, Burkard T, Weisser M. Treatment Strategies to Control Blood Pressure in People With Hypertension in Tanzania and Lesotho: A Randomized Clinical Trial. JAMA Cardiol. 2025 Apr 1;10(4):321-333. doi: 10.1001/jamacardio.2024.5124.

  PMID: 39878989 DERIVED

• 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.

  PMID: 33478567 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maja Weisser Rohacek, PD Dr.

  Division of Infectious Diseases & Hospital Epidemiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 17, 2019
• Study Start: March 5, 2020
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

CH (1); TA (1); LE (1)