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

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ClinicalTrials.gov Identifier: NCT04129840
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
Swiss National Fund for Scientific Research
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment Phase
Arterial Hypertension Other: dual combination Other: triple combination Other: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1078 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa - A Randomized Controlled Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention 1: dual combination
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
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)

Active Comparator: Intervention 2: triple combination
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
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)

Placebo Comparator: Standard of care
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
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)




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129840


Contacts
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Contact: Maja Weisser Rohacek, PD Dr. +41 (0)61 328 67 42 m.weisser@unibas.ch
Contact: Niklaus Labhardt n.labhardt@unibas.ch

Locations
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Lesotho
SolidarMed Lesotho, Mokhotlong Government Hospital Not yet recruiting
Mokhotlong, Lesotho
Contact: Ravi Gupta, Dr. med       R.Gupta@solidarmed.ch   
Contact: Madavida Mphunyan       mphunyanem@gmail.com   
Sub-Investigator: Alain Amstutz         
Switzerland
Division of Infectious Diseases & Hospital Epidemiology; University Hospital Basel Not yet recruiting
Basel, Switzerland, 4031
Contact: Maja Weisser Rohacek, PD Dr. med       m.weisser@unibas.ch   
Contact: Niklaus Labhardt       n.labhardt@unibas.ch   
Sub-Investigator: Thilo Burkard         
Sub-Investigator: Günther Fink         
Sub-Investigator: Mark Lambrinis         
Tanzania
St. Francis Referral Hospital/ Ifakara Health Institute Not yet recruiting
Ifakara, Morogoro, Tanzania
Contact: Herry Mapesi, Dr. med       hmapesi@ihi.or.tz   
Contact: Martin Rohacek       hmapesi@ihi.or.tz   
Sub-Investigator: Herieth Wilson         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Fund for Scientific Research
Investigators
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Principal Investigator: Maja Weisser Rohacek, PD Dr. Division of Infectious Diseases & Hospital Epidemiology, University Hospital Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04129840     History of Changes
Other Study ID Numbers: 2019-00817; qu19Weisser
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
antihypertensive treatment
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases