Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swiss National Fund for Scientific Research | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 4, 8 and 24 weeks after enrolment |
| Change in blood pressure (mmHg) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maja Weisser Rohacek, PD Dr. | Division of Infectious Diseases & Hospital Epidemiology, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SolidarMed Lesotho, Mokhotlong Government Hospital | Mokhotlong | Lesotho | ||||
| Division of Infectious Diseases & Hospital Epidemiology; University Hospital Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39878989 | Derived | 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. | |
| 33478567 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
The intervention is a treatment algorithm (comparing two combination treatment strategies with the World Health Organization (WHO) standard and not an individual drug.
Not provided
Not provided
Not provided
Not provided
|
| 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) |
|
Change in blood pressure (change from enrolment) (mmHg) |
| at 4, 8, 12, 24 weeks after enrolment |
| 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 |
| 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 |
| 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 | within 24 weeks after enrolment |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Cost-effectiveness of the 3 treatment algorithms | Cost-effectiveness of the 3 treatment algorithms | within 24 weeks after enrolment |
| 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 |
| 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 |
| 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 |
| Basel |
| 4031 |
| Switzerland |
| St. Francis Referral Hospital/ Ifakara Health Institute | Ifakara | Morogoro | Tanzania |
| 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. |