Status:
COMPLETED
Identifying Most Effective Treatment Strategies to Control Arterial Hypertension in Sub-Saharan Africa
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Swiss National Fund for Scientific Research
Conditions:
Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2022
Estimated Enrollment :
1268 Patients enrolled
Trial Details
Trial ID
NCT04129840
Start Date
March 5 2020
End Date
September 22 2022
Last Update
October 20 2022
Active Locations (3)
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1
SolidarMed Lesotho, Mokhotlong Government Hospital
Mokhotlong, Lesotho
2
Division of Infectious Diseases & Hospital Epidemiology; University Hospital Basel
Basel, Switzerland, 4031
3
St. Francis Referral Hospital/ Ifakara Health Institute
Ifakara, Morogoro, Tanzania