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NCT Number: NCT04129840

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

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.

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Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SolidarMed Lesotho, Mokhotlong Government Hospital, Mokhotlong, Lesotho

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

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)

Primary outcomes

  1. Proportion of patients reaching a target blood pressure

    Time frame: 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 outcomes

  1. Proportion of patients reaching a target blood pressure

    Time frame: 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

  2. Change in blood pressure (mmHg)

    Time frame: at 4, 8, 12, 24 weeks after enrolment

    Change in blood pressure (change from enrolment) (mmHg)

  3. Proportion of patients with treatment adaptations made to the primary treatment

    Time frame: within 12 weeks after enrolment

    Proportion of patients with treatment adaptations made to the primary treatment (dose increases and/or drug additions)

  4. Number of treatment adaptations per patient made to the primary treatment

    Time frame: within 12 weeks after enrolment

    Number of treatment adaptations per patient made to the primary treatment

  5. Time until first target blood pressure of </=130/80 mmHg in patients <65years of age and </=140/90mmHg in patients >65years of age

    Time frame: 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

  6. Proportion of patients with major cardiovascular endpoints

    Time frame: within 24 weeks after enrolment

    Proportion of patients with major cardiovascular endpoints such as death, stroke, myocardial infarction, heart failure)

  7. Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage

    Time frame: within 24 weeks after enrolment

    Proportion of patients with changes in surrogate markers for hypertension-mediated organ damage (resolving, newly occurring or worsening)

  8. Proportion of patients lost to follow up or stopped treatment

    Time frame: within 24 weeks after enrolment

    Proportion of patients lost to follow up or stopped treatment

  9. Proportion of patients with at least one grade 3/4 adverse event

    Time frame: within 24 weeks after enrolment

    Proportion of patients with at least one grade 3/4 adverse event

  10. Proportion of patients with at least one severe adverse event

    Time frame: within 24 weeks after enrolment

    Proportion of patients with at least one severe adverse event

  11. Proportion of patients who were non-adherent to drugs

    Time frame: at 12 weeks after enrolment

    Proportion of patients who were non-adherent to drugs (<90% pill count or <90% of self-reported drug intake)

  12. Reasons for non-adherence assessed by pill count (descriptive analysis)

    Time frame: within 24 weeks after enrolment

    Reasons for non-adherence assessed by pill count (descriptive analysis)

  13. Cost-effectiveness of the 3 treatment algorithms

    Time frame: within 24 weeks after enrolment

    Cost-effectiveness of the 3 treatment algorithms

  14. Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement

    Time frame: within 12 weeks after enrolment

    Proportion of patients with white coat hypertension, as determined by 24h ambulatory blood pressure measurement

  15. Proportion of patients with blood pressure control determined by 24h ambulatory blood pressure measurement (24h mean blood pressure <130/80mmHg irrespective of age)

    Time frame: 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)

  16. Reasons for non-adherence assessed by self-report (descriptive analysis)

    Time frame: within 24 weeks after enrolment

    Reasons for non-adherence assessed by self-report (descriptive analysis)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Swiss National Fund for Scientific Research

Registry information

Official study title

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

Acronym: coArtHA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2019
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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