Abstract
BackgroundPrimary aldosteronism (PA) affects approximately 5 to 10% of all patients with arterial hypertension and is associated with an excess rate of cardiovascular complications that can be significantly reduced by a targeted treatment. There exists a general consensus that the aldosterone to renin ratio should be used as a screening tool but valid data about the accuracy of the aldosterone to renin ratio in screening for PA are sparse. In the Graz endocrine causes of hypertension (GECOH) study we aim to prospectively evaluate diagnostic procedures for PA.Methods and designIn this single center, diagnostic accuracy study we will enrol 400 patients that are routinely referred to our tertiary care center for screening for endocrine hypertension. We will determine the aldosterone to active renin ratio (AARR) as a screening test. In addition, all study participants will have a second determination of the AARR and will undergo a saline infusion test (SIT) as a confirmatory test. PA will be diagnosed in patients with at least one AARR of ≥ 5.7 ng/dL/ng/L (including an aldosterone concentration of ≥ 9 ng/dL) who have an aldosterone level of ≥ 10 ng/dL after the saline infusion test. As a primary outcome we will calculate the receiver operating characteristic curve of the AARR in diagnosing PA. Secondary outcomes include the test characteristics of the saline infusion test involving a comparison with 24 hours urine aldosterone levels and the accuracy of the aldosterone to renin activity ratio in diagnosing PA. In addition we will evaluate whether the use of beta-blockers significantly alters the accuracy of the AARR and we will validate our laboratory methods for aldosterone and renin.ConclusionScreening for PA with subsequent targeted treatment is of great potential benefit for hypertensive patients. In the GECOH study we will evaluate a standardised procedure for screening and diagnosing of this disease.
Highlights
Primary aldosteronism (PA) affects approximately 5 to 10% of all patients with arterial hypertension and is associated with an excess rate of cardiovascular complications that can be significantly reduced by a targeted treatment
Screening for PA with subsequent targeted treatment is of great potential benefit for hypertensive patients
Our main study aims are (1) to test the accuracy of the aldosterone to active renin ratio (AARR) in screening for PA, (2) to test the accuracy of the saline infusion test (SIT) and (3) to evaluate whether the use of beta-blockers significantly alters the accuracy of the AARR as a screening test for PA. (4) In the first 100 patients of our study we aim to compare our laboratory methods for aldosterone and renin with other widely used and validated assays and (5) we will calculate the accuracy of the ARR in diagnosing PA and compare it with the accuracy of the AARR. (6) We will evaluate the test characteristics of the SIT in comparison with PA diagnosis based on 24 hours urine aldosterone levels
Summary
Primary aldosteronism (PA) affects approximately 5 to 10% of all patients with arterial hypertension and is associated with an excess rate of cardiovascular complications that can be significantly reduced by a targeted treatment. After removal of the affected adrenal gland, patients with APA are cured from hypertension in approximately half of the cases with an improvement of hypertension in the remainder [1,2,3]. This surgical therapy is considered cost-effective [9]. Patients with BAH respond well to drug therapy with mineralcorticoid receptor antagonists [13,7]
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