An interventional study of dual combination and triple combination in Arterial Hypertension, sponsored by University Hospital, Basel, Switzerland. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-20.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Other
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 1,268 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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)
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)
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)
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
Time frame: at 12 weeks after enrolment
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
Time frame: at 4, 8 and 24 weeks after enrolment
Change in blood pressure (mmHg)
Change in blood pressure (change from enrolment) (mmHg)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: within 24 weeks after enrolment
Cost-effectiveness of the 3 treatment algorithms
Cost-effectiveness of the 3 treatment algorithms
Time frame: 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
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)
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
Reasons for non-adherence assessed by self-report (descriptive analysis)
Reasons for non-adherence assessed by self-report (descriptive analysis)
Time frame: within 24 weeks after enrolment
Ran from Mar 2020 to primary completion in Sep 2022, 30 months.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 30 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →