Primary AldosteronismODEPRASCNCT06740838
Overnight Dexamethasone in Primary Aldosteronism Screening
An observational study of Primary Aldosteronism and Hypertension, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Primary Aldosteronism, Hypertension
- How many people
- 240 participants
- Where
- 1 sitePoland
- Study dates
- 22 Oct 2024to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Internal Medicine, University Clinical Center, Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80214
Piotr Kmiec, MD, Ph.D., 0048 585844809, piotrkmiec@gumed.edu.pl
Renata Swiatkowska-Stodulska, Professor, MD, Ph.D., 0048 58 5844800, rensto@gumed.edu.pl
About this study
Official title: 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.
Read more
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.
Read the 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
- Eliminating the effect of ACTH on Ald release will result in better interpretability of ARR and/or renin and Ald thresholds, and
- 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.
- Conditions
- Primary Aldosteronism, Hypertension
- Keywords
- primary aldosteronism, screening, renin, aldosterone, hypertension, corticotropin, dexamethasone
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Overall diagnostic accuracy of post-DXM ARR
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
Measured: 24 months
Secondary outcomes (1)
Association between post-DXM ARR and 24-h urinary aldosteronuria in the oral salt loading test
Post-DXM ARRs on different medications will be investigated for correlations or other associations with urinary aldosteronuria in the OSLT.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start22 Oct 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Kmiec, MD, Ph.D., Principal investigator, Department of Endocrinology and Internal Medicine, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740838
- Sponsor's protocol ID
- NKBBN 287-76/2021
- Acronym
- ODEPRASC
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IRB approval and participant consent do not cover sharing IPD outside the scope of the study.
Publications
Upton TJ, Zavala E, Methlie P, Kampe O, Tsagarakis S, Oksnes M, Bensing S, Vassiliadi DA, Grytaas MA, Botusan IR, Ueland G, Berinder K, Simunkova K, Balomenaki M, Margaritopoulos D, Henne N, Crossley R, Russell G, Husebye ES, Lightman SL. High-resolution daily profiles of tissue adrenal steroids by portable automated collection. Sci Transl Med. 2023 Jun 21;15(701):eadg8464. doi: 10.1126/scitranslmed.adg8464. Epub 2023 Jun 21.
PubMed 37343084Yozamp N, Hundemer GL, Moussa M, Underhill J, Fudim T, Sacks B, Vaidya A. Intraindividual Variability of Aldosterone Concentrations in Primary Aldosteronism: Implications for Case Detection. Hypertension. 2021 Mar 3;77(3):891-899. doi: 10.1161/HYPERTENSIONAHA.120.16429. Epub 2020 Dec 7.
PubMed 33280409Markou A, Sertedaki A, Kaltsas G, Androulakis II, Marakaki C, Pappa T, Gouli A, Papanastasiou L, Fountoulakis S, Zacharoulis A, Karavidas A, Ragkou D, Charmandari E, Chrousos GP, Piaditis GP. Stress-induced Aldosterone Hyper-Secretion in a Substantial Subset of Patients With Essential Hypertension. J Clin Endocrinol Metab. 2015 Aug;100(8):2857-64. doi: 10.1210/jc.2015-1268. Epub 2015 May 14.
PubMed 25974737Papanastasiou L, Markou A, Pappa T, Gouli A, Tsounas P, Fountoulakis S, Kounadi T, Tsiama V, Dasou A, Gryparis A, Samara C, Zografos G, Kaltsas G, Chrousos G, Piaditis G. Primary aldosteronism in hypertensive patients: clinical implications and target therapy. Eur J Clin Invest. 2014 Aug;44(8):697-706. doi: 10.1111/eci.12286.
PubMed 24909545Gouli A, Kaltsas G, Tzonou A, Markou A, Androulakis II, Ragkou D, Vamvakidis K, Zografos G, Kontogeorgos G, Chrousos GP, Piaditis G. High prevalence of autonomous aldosterone secretion among patients with essential hypertension. Eur J Clin Invest. 2011 Nov;41(11):1227-36. doi: 10.1111/j.1365-2362.2011.02531.x. Epub 2011 May 3.
PubMed 21534948Markou A, Kaltsas GA, Papanastasiou L, Gravvanis C, Voulgaris N, Kanti G, Zografos GN, Chrousos GP, Piaditis G. Enhanced performance of a modified diagnostic test of primary aldosteronism in patients with adrenal adenomas. Eur J Endocrinol. 2022 Jan 6;186(2):265-273. doi: 10.1530/EJE-21-0625.
PubMed 34882580Li X, Liang J, Hu J, Ma L, Yang J, Zhang A, Jing Y, Song Y, Yang Y, Feng Z, Du Z, Wang Y, Luo T, He W, Shu X, Yang S, Li Q; Chongqing Primary Aldosteronism Study (CONPASS) Group. Screening for primary aldosteronism on and off interfering medications. Endocrine. 2024 Jan;83(1):178-187. doi: 10.1007/s12020-023-03520-6. Epub 2023 Oct 5.
PubMed 37796417Seifarth C, Trenkel S, Schobel H, Hahn EG, Hensen J. Influence of antihypertensive medication on aldosterone and renin concentration in the differential diagnosis of essential hypertension and primary aldosteronism. Clin Endocrinol (Oxf). 2002 Oct;57(4):457-65. doi: 10.1046/j.1365-2265.2002.01613.x.
PubMed 12354127Browne GA, Griffin TP, O'Shea PM, Dennedy MC. beta-Blocker withdrawal is preferable for accurate interpretation of the aldosterone-renin ratio in chronically treated hypertension. Clin Endocrinol (Oxf). 2016 Mar;84(3):325-31. doi: 10.1111/cen.12882. Epub 2015 Sep 22.
PubMed 26300226Brown JM, Robinson-Cohen C, Luque-Fernandez MA, Allison MA, Baudrand R, Ix JH, Kestenbaum B, de Boer IH, Vaidya A. The Spectrum of Subclinical Primary Aldosteronism and Incident Hypertension: A Cohort Study. Ann Intern Med. 2017 Nov 7;167(9):630-641. doi: 10.7326/M17-0882. Epub 2017 Oct 10.
PubMed 29052707Parksook WW, Brown JM, Omata K, Tezuka Y, Ono Y, Satoh F, Tsai LC, Niebuhr Y, Milks J, Moore A, Honzel B, Liu H, Auchus RJ, Sunthornyothin S, Turcu AF, Vaidya A. The Spectrum of Dysregulated Aldosterone Production: An International Human Physiology Study. J Clin Endocrinol Metab. 2024 Aug 13;109(9):2220-2232. doi: 10.1210/clinem/dgae145.
PubMed 38450549McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.
PubMed 39210715Mulatero P, Sechi LA, Williams TA, Lenders JWM, Reincke M, Satoh F, Januszewicz A, Naruse M, Doumas M, Veglio F, Wu VC, Widimsky J. Subtype diagnosis, treatment, complications and outcomes of primary aldosteronism and future direction of research: a position statement and consensus of the Working Group on Endocrine Hypertension of the European Society of Hypertension. J Hypertens. 2020 Oct;38(10):1929-1936. doi: 10.1097/HJH.0000000000002520.
PubMed 32890265Mulatero P, Monticone S, Deinum J, Amar L, Prejbisz A, Zennaro MC, Beuschlein F, Rossi GP, Nishikawa T, Morganti A, Seccia TM, Lin YH, Fallo F, Widimsky J. Genetics, prevalence, screening and confirmation of primary aldosteronism: a position statement and consensus of the Working Group on Endocrine Hypertension of The European Society of Hypertension. J Hypertens. 2020 Oct;38(10):1919-1928. doi: 10.1097/HJH.0000000000002510.
PubMed 32890264Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
PubMed 26934393
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Dexamethasone in Primary Aldosteronism Screening in Patients on Interfering Therapy (the ODEPRASC Study)
- ClinicalTrials.gov ID
- NCT06740838
- Acronym / sponsor ID
- ODEPRASC / NKBBN 287-76/2021
- Conditions
- Primary Aldosteronism, Hypertension
- Keywords
- primary aldosteronism, screening, renin, aldosterone, hypertension, corticotropin, dexamethasone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Eliminating the effect of ACTH on Ald release will result in better interpretability of ARR and/or renin and Ald thresholds, and
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Association between post-DXM ARR and 24-h urinary aldosteronuria in the oral salt loading test
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 37343084Upton TJ, Zavala E, Methlie P, Kampe O, Tsagarakis S, Oksnes M, Bensing S, Vassiliadi DA, Grytaas MA, Botusan IR, Ueland G, Berinder K, Simunkova K, Balomenaki M, Margaritopoulos D, Henne N, Crossley R, Russell G, Husebye ES, Lightman SL. High-resolution daily profiles of tissue adrenal steroids by portable automated collection. Sci Transl Med. 2023 Jun 21;15(701):eadg8464. doi: 10.1126/scitranslmed.adg8464. Epub 2023 Jun 21.
- Background: PubMed 33280409Yozamp N, Hundemer GL, Moussa M, Underhill J, Fudim T, Sacks B, Vaidya A. Intraindividual Variability of Aldosterone Concentrations in Primary Aldosteronism: Implications for Case Detection. Hypertension. 2021 Mar 3;77(3):891-899. doi: 10.1161/HYPERTENSIONAHA.120.16429. Epub 2020 Dec 7.
- Background: PubMed 25974737Markou A, Sertedaki A, Kaltsas G, Androulakis II, Marakaki C, Pappa T, Gouli A, Papanastasiou L, Fountoulakis S, Zacharoulis A, Karavidas A, Ragkou D, Charmandari E, Chrousos GP, Piaditis GP. Stress-induced Aldosterone Hyper-Secretion in a Substantial Subset of Patients With Essential Hypertension. J Clin Endocrinol Metab. 2015 Aug;100(8):2857-64. doi: 10.1210/jc.2015-1268. Epub 2015 May 14.
- Background: PubMed 24909545Papanastasiou L, Markou A, Pappa T, Gouli A, Tsounas P, Fountoulakis S, Kounadi T, Tsiama V, Dasou A, Gryparis A, Samara C, Zografos G, Kaltsas G, Chrousos G, Piaditis G. Primary aldosteronism in hypertensive patients: clinical implications and target therapy. Eur J Clin Invest. 2014 Aug;44(8):697-706. doi: 10.1111/eci.12286.
- Background: PubMed 21534948Gouli A, Kaltsas G, Tzonou A, Markou A, Androulakis II, Ragkou D, Vamvakidis K, Zografos G, Kontogeorgos G, Chrousos GP, Piaditis G. High prevalence of autonomous aldosterone secretion among patients with essential hypertension. Eur J Clin Invest. 2011 Nov;41(11):1227-36. doi: 10.1111/j.1365-2362.2011.02531.x. Epub 2011 May 3.
- Background: PubMed 34882580Markou A, Kaltsas GA, Papanastasiou L, Gravvanis C, Voulgaris N, Kanti G, Zografos GN, Chrousos GP, Piaditis G. Enhanced performance of a modified diagnostic test of primary aldosteronism in patients with adrenal adenomas. Eur J Endocrinol. 2022 Jan 6;186(2):265-273. doi: 10.1530/EJE-21-0625.
- Background: PubMed 37796417Li X, Liang J, Hu J, Ma L, Yang J, Zhang A, Jing Y, Song Y, Yang Y, Feng Z, Du Z, Wang Y, Luo T, He W, Shu X, Yang S, Li Q; Chongqing Primary Aldosteronism Study (CONPASS) Group. Screening for primary aldosteronism on and off interfering medications. Endocrine. 2024 Jan;83(1):178-187. doi: 10.1007/s12020-023-03520-6. Epub 2023 Oct 5.
- Background: PubMed 12354127Seifarth C, Trenkel S, Schobel H, Hahn EG, Hensen J. Influence of antihypertensive medication on aldosterone and renin concentration in the differential diagnosis of essential hypertension and primary aldosteronism. Clin Endocrinol (Oxf). 2002 Oct;57(4):457-65. doi: 10.1046/j.1365-2265.2002.01613.x.
- Background: PubMed 26300226Browne GA, Griffin TP, O'Shea PM, Dennedy MC. beta-Blocker withdrawal is preferable for accurate interpretation of the aldosterone-renin ratio in chronically treated hypertension. Clin Endocrinol (Oxf). 2016 Mar;84(3):325-31. doi: 10.1111/cen.12882. Epub 2015 Sep 22.
- Background: PubMed 29052707Brown JM, Robinson-Cohen C, Luque-Fernandez MA, Allison MA, Baudrand R, Ix JH, Kestenbaum B, de Boer IH, Vaidya A. The Spectrum of Subclinical Primary Aldosteronism and Incident Hypertension: A Cohort Study. Ann Intern Med. 2017 Nov 7;167(9):630-641. doi: 10.7326/M17-0882. Epub 2017 Oct 10.
- Background: PubMed 38450549Parksook WW, Brown JM, Omata K, Tezuka Y, Ono Y, Satoh F, Tsai LC, Niebuhr Y, Milks J, Moore A, Honzel B, Liu H, Auchus RJ, Sunthornyothin S, Turcu AF, Vaidya A. The Spectrum of Dysregulated Aldosterone Production: An International Human Physiology Study. J Clin Endocrinol Metab. 2024 Aug 13;109(9):2220-2232. doi: 10.1210/clinem/dgae145.
- Background: PubMed 39210715McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.
- Individual participant dataSharing planned: No. IRB approval and participant consent do not cover sharing IPD outside the scope of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piotr Kmiec, MD, Ph.D. principal investigator
Department of Endocrinology and Internal Medicine, Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and Hypertension, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Kmiec, M.D., Ph.D. (0048 585844809, piotrkmiec@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall diagnostic accuracy of post-DXM ARR (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06740838, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.