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Table 2 Secondary endpoints and nested studies

From: The coArtHA trial—identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial

Endpoint

Time point after randomization

Remarks

Proportion of participants reaching a target BP of ≤130/80 mmHg in patients < 65 years of age and ≤ 140/90 mmHg in patients ≥ 65 years of age

At 4, 8, and 24 weeks

Same definition of target BP* as for the primary endpoint at 12 weeks

Change in BP from enrolment

At 4, 8, 12, and 24 weeks

Reduction in mmHg

Proportion of participants with treatment adaptations made to the primary treatment

By 12 weeks

Dose increase or decrease, and/or drug additions

Proportion of participants with a blood pressure decrease of at least 20/10 mmHg

4, 8, 12, and 24 weeks

 

Number of treatment adaptations per participant made to the primary treatment

By 12 weeks

Dose increase or decrease, and/or drug additions

Time until target BP is (first) reached

Over 24 weeks

Censoring at last visit for those not observed to reach the target BP*, and for patients who achieve the target BP* any subsequent rebounds will be described but not included in this analysis

Proportion of participants with changes in surrogate markers for hypertension-mediated organ damage (resolving, newly occurring or worsening)

Over 24 weeks

Surrogate markers of organ damage

• Kidney impairment: decrease in eGFR (CKD-EPI formula); increase in proteinuria, measured by albumin/creatinine ratio or

• Hypertensive heart disease:

 • Positive Sokolow-Lyon Index (Sokolow-Lyon voltage (SV1 + RV5/V6 ≥ 3.5 mV and/or RaVL ≥ 1.1 mV) on ECG [46, 47]) or

 • Signs of left ventricular hypertrophy [48] or left atrial remodeling/enlargement assessed by focused echocardiography [49, 50] or

• Retinopathy: assessed by retinal picture [51].

Proportion of participants with major cardiovascular endpoints

Over 24 weeks

Major clinical endpoints of mortality, major cardiovascular events such as stroke, myocardial infarction, heart failure, end-stage kidney disease

Proportion of participants lost to follow-up or stopped treatment

Over 24 weeks

 

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

Over 24 weeks

Adverse events will be graded according to the CTCAE v5.0, January 2018

Proportion of participants with at least one severe adverse event

Over 24 weeks

 

Proportion of participants who were non-adherent to study drugs

Over 12 weeks

< 90% pill count or < 90% of self-reported drug intake

Reasons for non-adherence assessed by pill count and self-report

Over 12 weeks

Descriptive analysis

  1. BP blood pressure, eGFR estimated glomerular filtration rate, CKD-EPI Chronic Kidney Disease Epidemiology Collaboration, ECG electrocardiogram, CTCAE Common Terminology Criteria for Adverse Events, HIV human immunodeficiency virus
  2. *Target BP is defined as ≤ 130/80 mmHg among participants aged < 65 years and ≤ 140/90 mmHg among participants aged ≥ 65 years