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Overnight Dexamethasone in Primary Aldosteronism Screening in Patients on Interfering Therapy (ODEPRASC): A
Piotr Kmieć1,2, Dominika Okroj1,2, Małgorzata Zdrojewska1,2
1Department of Endocrinology and Internal Medicine, Medical University of Gdańsk, Gdańsk, Poland.
Abstract:
Screening for primary aldosteronism (PA) remains exceedingly low, despite the fact that the disorder contributes to or underlies hypertension (HT) in as many as 20% of unselected patients. Conventionally, withdrawal of medications interfering with the renin‒angiotensin‒aldosterone system (RAAS) has been recommended before PA work-up. Previous research showed that combining objective thresholds and 2-day cosyntropin suppression was highly accurate in diagnosing PA among HT patients off interfering drugs. Here, we present the protocol of a study designed to generate and temporally validate aldosterone-to-renin ratio (ARR) thresholds following overnight cosyntropin suppression in PA screening on interfering medications. We hypothesize that overnight cosyntropin suppression with 1 mg dexamethasone will result in 25% higher diagnostic interpretability compared to conventional ARR testing. This single-center study consists of a development and confirmation cohort (both n = 80). Patients with an adrenal incidentaloma are enrolled in a 1-day clinic. Aldosterone-to-renin ratios (ARRs) are determined before and after overnight intake of 1 mg dexamethasone (DXM) on, partially off, and off medications interfering with the RAAS. Emphasis on screening and limitation of PA confirmatory (suppression) tests have been included in the current Endocrine Society guideline on PA due to low evidence of benefits of the latter in diagnosing the disorder. In light of poor PA screening rates, the ODEPRASC study may provide a rationale for an optimized diagnostic approach. Trial Registration: ClinicalTrials.gov identifier: NCT06740838.
Insights
Screening for primary aldosteronism (PA), a common cause of hypertension, can be improved. This study investigates overnight dexamethasone suppression testing for more accurate PA diagnosis, even with interfering medications.
Area of Science:
- Endocrinology
- Hypertension Management
- Diagnostic Accuracy
Background:
- Primary aldosteronism (PA) is a frequent cause of hypertension (HT), yet screening rates are low.
- Current PA diagnostic guidelines recommend medication withdrawal, which is often impractical.
- Previous methods combining objective thresholds and 2-day cosyntropin suppression showed high accuracy in specific patient groups.
Purpose of the Study:
- To develop and validate aldosterone-to-renin ratio (ARR) thresholds for PA screening using overnight cosyntropin suppression.
- To assess the diagnostic interpretability of PA screening in patients taking interfering medications.
- To provide an optimized diagnostic approach for PA, addressing low screening rates.
Main Methods:
- A single-center study with development and confirmation cohorts (n=80 each).
- Patients with adrenal incidentaloma undergo a 1-day clinic evaluation.
- Aldosterone-to-renin ratios (ARRs) measured before and after overnight 1mg dexamethasone (DXM) intake, with varying degrees of RAAS-interfering medication withdrawal.
Main Results:
- The study protocol aims to generate and validate ARR thresholds for PA screening.
- Hypothesis: Overnight DXM suppression will yield 25% higher diagnostic interpretability than conventional ARR testing.
- The ODEPRASC study is designed to address limitations in current PA diagnostic protocols.
Conclusions:
- The proposed overnight cosyntropin suppression test offers a potentially more practical and accurate method for PA screening.
- This approach may improve PA diagnosis rates, especially in patients on interfering medications.
- Findings could inform future guidelines for PA diagnosis and management.
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