NCT04129840

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

Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa - A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,268 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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)
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)
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)

Timeline

• Start date: 2020-03-05
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2019-10-17
• Last updated: 2022-10-20

Locations

3 sites across 3 countries: Lesotho, Switzerland, Tanzania