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Arterial HypertensioncoArtHANCT04129840

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

A study testing dual combination and triple combination in people with Arterial Hypertension, run by University Hospital, Basel, Switzerland at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arterial Hypertension
What is being tested?
dual combination and triple combination
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,268 participants
Where
3 sitesin 3 countries
Study dates
5 Mar 2020to 22 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Lesotho1 site

  • SolidarMed Lesotho, Mokhotlong Government Hospital

    Mokhotlong

Other trials in Lesotho

Switzerland1 site

  • Division of Infectious Diseases & Hospital Epidemiology; University Hospital Basel

    Basel, 4031

Other trials in Switzerland

Tanzania1 site

  • St. Francis Referral Hospital/ Ifakara Health Institute

    Ifakara, Morogoro

Other trials in Tanzania

About this study

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

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.

Being tested
dual combination, triple combination, Standard of care
Keywords
antihypertensive treatment
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dual combinationOther

    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 combinationOther

    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 careOther

    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)

Study groups in NCT04129840
Study groupRoleWhat they receive
Intervention 1: dual combinationActive comparatordual 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
Receives: Other: dual combination
Intervention 2: triple combinationActive comparatortriple 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
Receives: Other: triple combination
Standard of carePlacebo comparatorstart 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
Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at 12 weeks after enrolment

Secondary outcomes (16)

  1. Proportion of patients reaching a target blood pressure

    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

    Measured: at 4, 8 and 24 weeks after enrolment

  2. Change in blood pressure (mmHg)

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

    Measured: at 4, 8, 12, 24 weeks after enrolment

  3. 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)

    Measured: within 12 weeks after enrolment

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

    Number of treatment adaptations per patient made to the primary treatment

    Measured: within 12 weeks after enrolment

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

    Measured: within 24 weeks after enrolment

  6. Proportion of patients with major cardiovascular endpoints

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

    Measured: within 24 weeks after enrolment

  7. 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)

    Measured: within 24 weeks after enrolment

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

    Proportion of patients lost to follow up or stopped treatment

    Measured: within 24 weeks after enrolment

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

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

    Measured: within 24 weeks after enrolment

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

    Proportion of patients with at least one severe adverse event

    Measured: within 24 weeks after enrolment

  11. 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)

    Measured: at 12 weeks after enrolment

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

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

    Measured: within 24 weeks after enrolment

  13. Cost-effectiveness of the 3 treatment algorithms

    Cost-effectiveness of the 3 treatment algorithms

    Measured: within 24 weeks after enrolment

  14. 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

    Measured: within 12 weeks after enrolment

  15. 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)

    Measured: within 12 weeks after enrolment

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

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

    Measured: within 24 weeks after enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2019
  2. Study start5 Mar 2020
  3. Primary completion22 Sep 2022
  4. Study completion22 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention is a treatment algorithm (comparing two combination treatment strategies with the World Health Organization (WHO) standard and not an individual drug.
Masking
None (open label)
Enrolment
1,268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129840
Sponsor's protocol ID
2019-00817; qu19Weisser
Other IDs
2019
Acronym
coArtHA
Status last verified
Oct 2022
First submitted
3 Oct 2019
Last updated
20 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vischer AS, Nemtsova V, Lukau B, Rohacek M, Macko J, Oehri J, Mapesi H, Vanobberghen F, Katende A, Gupta R, Wilson HI, Amstutz A, Senkoro E, Byakuzana T, Mbunda G, Siru J, Gingo W, Labhardt ND, Weisser M, Burkard T. ECG Criteria for Left Ventricular Hypertrophy in Hypertensive Black Africans: Insights from the coArtHA Trial. Glob Heart. 2026 Jul 21;21(1):57. doi: 10.5334/gh.1562. eCollection 2026.

    PubMed 42499811

  • 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.

    PubMed 39878989

  • 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.

    PubMed 33478567

Questions about this trial

What is this clinical trial studying?

A study testing dual combination and triple combination in people with Arterial Hypertension, run by University Hospital, Basel, Switzerland at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Lesotho, Switzerland, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients reaching a target blood pressure (time frame: at 12 weeks after enrolment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04129840, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.

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