Overnight Dexamethasone in Primary Aldosteronism Screening (ODEPRASC)

September 27, 2025 updated by: Medical University of Gdansk

Overnight Dexamethasone in Primary Aldosteronism Screening in Patients on Interfering Therapy (the ODEPRASC Study)

The goal of this observational study is to learn whether screening for primary aldosteronism can be improved among patients on chronic blood pressure-lowering medications by ordering intake of 1 mg of dexamethasone prior to hormonal examinations.

Primary aldosteronism is a condition, in which an adrenal gland steroid aldosterone is released in excessive amounts; it commonly causes hypertension but requires specific therapy different from usually prescribed in other forms of hypertension.

Dexamethasone is a synthetic steroid used for both therapeutic and diagnostic purposes. A single 1 mg dexamethasone dose taken at 11 p.m. in order to measure hormone concentrations the following morning (so called overnight 1-mg dexamethasone test) is a commonly applied test in the work-up of adrenal disorders.

The main question the project aims to answer is:

Can screening for primary aldosteronism be improved among patients receiving blood pressure-lowering medications with overnight 1-mg dexamethasone intake?

Participants will undergo changes in their chronic medication to be able to definitely rule out or confirm primary aldosteronism in blood hormonal examinations. These modifications and modifications are not part of the research project.

For this project participants will be asked to

  • undergo the 1-mg dexamethasone test one to three times in order to compare hormonal concentrations before and after it,
  • collect urine for 24 hours to determine aldosterone in the urine sample after medications interfering in aldosterone release are temporarily withdrawn.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background Primary aldosteronism (PA) underlies or contributes to hypertension (HT) in up to 30% of patients. In the last two decades PA has been demonstrated to encompass mild forms, which do not meet established diagnostic criteria, yet are still clinically relevant. However, PA has been shown to be vastly underdiagnosed: less than 5% of patients from at-risk populations undergo screening.

One of the main reasons for low PA screening prevalence is the recommendation of hypotensive therapy modification prior to hormonal assessment, i.e. withdrawal of medications interfering in the renin-angiotensin-aldosterone system (RAAS) (2016 Endocrine Society guideline, 2020 European Society of Hypertension consensus statement). On the other hand, in many instances, PA may be diagnosed despite treatment with RAAS-interfering drugs.

Previous research showed efficacy in the diagnostic approach toward PA can be greatly improved by incorporating adrenocorticotropic hormone (ACTH) suppression. This was achieved by determining PA screening and confirmatory thresholds following a 2-day 2-mg/day dexamethasone (DXM) test. Patients diagnosed with PA by meeting these novel diagnostic criteria responded well to mineralocorticoid receptor antagonists.

These two diagnostic approaches (work-up in patients receiving RAAS-interfering drugs along with ACTH suppression) have not been combined so far.

Aim To generate and temporally validate PA screening thresholds (aldosterone-to-renin ratio, ARR, and aldosterone, Ald) among patients with HT receiving medications interfering in the RAAS by applying overnight ACTH suppression.

Methodology The project received the consent of the local bioethics committee. A development cohort of n=80, and a confirmation cohort of n=80, amount to 240 participants total due to an expected withdrawal rate of 33%. Study participants will be enrolled in a single, tertiary-care endocrine hospital in one-day clinic setting among hypertensive patients undergoing hormonal examinations due to the presence of an adrenocortical lesion with radiological features of an adenoma or hyperplasia (ACA or AHA, respectively). Only patients with indications for further PA testing upon a positive, permissive ARR will be recruited for participation in the study. Further diagnostic procedures (both in the course of this research and clinically-indicated) will be conducted in an outpatient endocrine clinic. Exclusion criteria include non-viability for RAAS-interfering medication modification.

Basal (1) ARR will be required for inclusion, while in the course of the project participants will undergo ARR measurements post-DXM on own (chronic) medications (2), pre- and post-DXM ARR upon partial modification of RAAS-interfering medications (3 and 4), and pre- and post-DXM upon temporary withdrawal of RAAS-interfering medications (5 and 6). An oral salt loading test, OSLT (one of established confirmatory PA tests), will be performed off interfering medications in all patients. Also, patients with a positive PA screening result will undergo either seated saline-infusion (SIT) and/or captopril challenge test (CCT) to confirm PA in a one-day clinic. Results of these confirmatory tests will be used as reference in determining sensitivity and specificity of PA screening thresholds on RAAS-interfering therapy regimens.

Statistical analysis will be performed upon gathering clinical and hormonal data to determine thresholds for ARR, aldosterone and renin to suggest optimal (simple but more accurate than currently applied) PA screening criteria.

Expected results The hypotheses of the project are

  1. Eliminating the effect of ACTH on Ald release will result in better interpretability of ARR and/or renin and Ald thresholds, and
  2. Complete withdrawal of RAAS-interfering medications is not required for PA screening upon ARR determination combined with ACTH suppression.

The objective of the study is demonstrating that ARR measurement following overnight 1-mg DXM intake reduces the equivocal rate in interpreting the ARR measurement in PA screening compared to conventional ARR.

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Renata Swiatkowska-Stodulska, Professor, MD, Ph.D.
  • Phone Number: 0049 585844800
  • Email: rensto@gumed.edu.pl

Study Locations

  • Poland
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80214
        • Recruiting
        • Department of Endocrinology and Internal Medicine, University Clinical Center, Medical University of Gdansk
        • Sub-Investigator:
          • Dominika Okroj, MD
        • Contact:
        • Contact:
          • Renata Swiatkowska-Stodulska, Professor, MD, Ph.D.
          • Phone Number: 0048 58 5844800
          • Email: rensto@gumed.edu.pl
        • Principal Investigator:
          • Piotr Kmiec, MD, Ph.D.
        • Sub-Investigator:
          • Renata Swiatkowska-Stodulska, Professor, MD, Ph.D.
        • Sub-Investigator:
          • Malgorzata Zdrojewska, MD, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • patients of the one-day endocrine clinic of the Department of Endocrinology and Internal Medicine of the University Clinical Center of the Medical University of Gdansk, admitted for hormonal work-up due to an adrenal lesion,
  • study design is cross-sectional

Description

Inclusion Criteria:

  • suspected or diagnosed HT,
  • age between 40 and 75,
  • available aldosterone and renin result at the time of one-day clinic stay,
  • scheduled 1-mg-DXM test (indicated for possible mild autonomous cortisol secretion, MACS),
  • presence of an adrenal lesion with radiologic features of adrenocortical adenoma/hyperplasia.

Exclusion Criteria:

  • baseline (pre-DXM) hyperreninemia (renin exceeding the upper limit of normal at the study site, i.e. 46.1 mIU/l, assay manufacturer: Diasorin),
  • baseline (pre-DXM) Ald<3 ng/dl,
  • overt clinical and/or biochemical features of adrenal hormone deficiency or excess other than MACS (8 a.m. cortisolemia in the 50-140 nmol/l range in the 1-mg DXM test),
  • therapy with glucocorticoids, non-steroidal anti-inflammatory drugs, hormonal replacement therapy, hormonal contraceptive therapy, and/or licorice intake,
  • established or suspected secondary HT other than due to PA,
  • comorbidities including: poorly controlled and/or other than type 2 diabetes mellitus (T2DM), present and past alcohol abuse, obesity grade 3 (i.e. body mass index of at least 40 kg/m2), severe CV disease disqualifying a patient from chronic medication modification, active malignancy, decompensated autoimmune disease as well as an autoimmune disease associated with cardiovascular and/or renal complications, estimated glomerular filtration rate (eGFR) below 45 ml/min/1.73m2, poor physical condition, lack and withdrawal of consent for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Post-DXM ARR development cohort
Data from the first half of participants data will be used to generate post-DXM ARR (and possibly Ald) thresholds, which will be subsequently temporally validated in the confirmatory cohort.
Post-DXM ARR confirmatory cohort
Post-DXM ARR thresholds will be applied among participants of the confirmatory cohort, however, these will also undergo the medication withdrawal, OSLT, and other PA confirmatory tests if indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall diagnostic accuracy of post-DXM ARR
Time Frame: 24 months
percentage of correctly categorized patients with hypertension on RAAS-interfering medications as either with clear or unclear PA screening threshold base on post-DXM ARR determination
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between post-DXM ARR and 24-h urinary aldosteronuria in the oral salt loading test
Time Frame: 24 months
Post-DXM ARRs on different medications will be investigated for correlations or other associations with urinary aldosteronuria in the OSLT.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Principal Investigator: Piotr Kmiec, MD, Ph.D., Department of Endocrinology and Internal Medicine, Medical University of Gdansk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

December 14, 2024

First Submitted That Met QC Criteria

December 14, 2024

First Posted (Actual)

December 18, 2024

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 27, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKBBN 287-76/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IRB approval and participant consent do not cover sharing IPD outside the scope of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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