Abstract
BackgroundSatisfactory tools to preclude low-risk patients from intensive diagnostic testing for primary aldosteronism (PA) are lacking. Therefore, we aimed to develop a decision tool to determine which patients with difficult-to-control hypertension have a low probability of PA, thereby limiting the exposure to invasive testing while at the same time increasing the efficiency of testing in the remaining patients.MethodsData from consecutive patients with difficult-to-control hypertension, analysed through a standardized diagnostic protocol between January 2010 and October 2017 (n = 824), were included in this cross-sectional study. PA was diagnosed by a combined approach: 1) elevated aldosterone-to-renin ratio (> 5.0 pmol/fmol/s), confirmed with 2) non-suppressible aldosterone after standardized saline infusion (≥280 pmol/L). Multivariable logistic regression analyses including seven pre-specified clinical variables (age, systolic blood pressure, serum potassium, potassium supplementation, serum sodium, eGFR and HbA1c) was performed. After correction for optimism, test reliability, discriminative performance and test characteristics were determined.ResultsPA was diagnosed in 40 (4.9%) of 824 patients. Predicted probabilities of PA agreed well with observed frequencies and the c-statistic was 0.77 (95% confidence interval (95%CI) 0.70–0.83). Predicted probability cut-off values of 1.0–2.5% prevented unnecessary testing in 8–32% of the patients with difficult-to-control hypertension, carrying sensitivities of 0.98 (95%CI 0.96–0.99) and 0.92 (0.83–0.97), and negative predictive values of 0.99 (0.98–1.00) and 0.99 (0.97–0.99).ConclusionsWith a decision tool, based on seven easy-to-measure clinical variables, patients with a low probability of PA can be reliably selected and a considerable proportion of patients with difficult-to-control hypertension can be spared intensive diagnostic testing.
Highlights
Satisfactory tools to preclude low-risk patients from intensive diagnostic testing for primary aldosteronism (PA) are lacking
In conclusion, with a decision tool based on seven easyto-measure clinical variables, patients with a low probability of PA can be reliably selected and a considerable proportion of patients with difficult-to-control hypertension can be spared further intensive diagnostic testing
Future perspectives By excluding patients at low risk for PA, the decision tool reduces the number of patients to be invasively tested and increases the efficiency of testing in the remaining patients, which will allow health-care providers to allocate their resources to patients with difficult-to-control hypertension at higher risk for PA
Summary
Satisfactory tools to preclude low-risk patients from intensive diagnostic testing for primary aldosteronism (PA) are lacking. We aimed to develop a decision tool to determine which patients with difficult-to-control hypertension have a low probability of PA, thereby limiting the exposure to invasive testing while at the same time increasing the efficiency of testing in the remaining patients. Many antihypertensive medications change renin and aldosterone levels, falsely increasing or decreasing the ARR, which leads to false positive or false negative test results [9, 10]. Aldosterone and renin levels are usually determined after cessation of antihypertensive medications that affect the ARR [8]. Medication washout raises safety concerns in patients with severe hypertension or individuals with a recent cardiovascular event in which tight blood pressure (BP) control is necessary. A substantial number of patients experience symptoms during the washout period: i.e. (worsening of) headache, fatigue or palpitations
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