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

Arterial Hypertension Clinical Trial

— coArtHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129840
• Other study ID #: 2019-00817; qu19Weisser
• Status: Completed
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: September 22, 2022

Study information

• Verified date: October 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1268
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Lesotho	SolidarMed Lesotho, Mokhotlong Government Hospital	Mokhotlong
Switzerland	Division of Infectious Diseases & Hospital Epidemiology; University Hospital Basel	Basel
Tanzania	St. Francis Referral Hospital/ Ifakara Health Institute	Ifakara	Morogoro

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Fund for Scientific Research

Countries where clinical trial is conducted

Lesotho,  Switzerland,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients reaching a target blood pressure	Proportion of patients reaching a target blood pressure (clinic blood pressure) of	at 12 weeks after enrolment
Secondary	Proportion of patients reaching a target blood pressure	Proportion of patients reaching a target blood pressure (clinic blood pressure) of	at 4, 8 and 24 weeks after enrolment
Secondary	Change in blood pressure (mmHg)	Change in blood pressure (change from enrolment) (mmHg)	at 4, 8, 12, 24 weeks after enrolment
Secondary	Proportion of patients with treatment adaptations made to the primary treatment	Proportion of patients with treatment adaptations made to the primary treatment (dose increases and/or drug additions)	within 12 weeks after enrolment
Secondary	Number of treatment adaptations per patient made to the primary treatment	Number of treatment adaptations per patient made to the primary treatment	within 12 weeks after enrolment
Secondary	Time until first target blood pressure of </=130/80 mmHg in patients <65years of age and </=140/90mmHg in patients >65years of age	Time until first target blood pressure of	within 24 weeks after enrolment
Secondary	Proportion of patients with major cardiovascular endpoints	Proportion of patients with major cardiovascular endpoints such as death, stroke, myocardial infarction, heart failure)	within 24 weeks after enrolment
Secondary	Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage	Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage (resolving, newly occurring or worsening)	within 24 weeks after enrolment
Secondary	Proportion of patients lost to follow up or stopped treatment	Proportion of patients lost to follow up or stopped treatment	within 24 weeks after enrolment
Secondary	Proportion of patients with at least one grade 3/4 adverse event	Proportion of patients with at least one grade 3/4 adverse event	within 24 weeks after enrolment
Secondary	Proportion of patients with at least one severe adverse event	Proportion of patients with at least one severe adverse event	within 24 weeks after enrolment
Secondary	Proportion of patients who were non-adherent to drugs	Proportion of patients who were non-adherent to drugs (<90% pill count or <90% of self-reported drug intake)	at 12 weeks after enrolment
Secondary	Reasons for non-adherence assessed by pill count (descriptive analysis)	Reasons for non-adherence assessed by pill count (descriptive analysis)	within 24 weeks after enrolment
Secondary	Cost-effectiveness of the 3 treatment algorithms	Cost-effectiveness of the 3 treatment algorithms	within 24 weeks after enrolment
Secondary	Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement	Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement	within 12 weeks after enrolment
Secondary	Proportion of patients with blood pressure control determined by 24h ambulatory blood pressure measurement (24h mean blood pressure <130/80mmHg irrespective of age)	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
Secondary	Reasons for non-adherence assessed by self-report (descriptive analysis)	Reasons for non-adherence assessed by self-report (descriptive analysis)	within 24 weeks after enrolment