NCT06740838Recruiting
Overnight Dexamethasone in Primary Aldosteronism Screening
Overnight Dexamethasone in Primary Aldosteronism Screening in Patients on Interfering Therapy (the ODEPRASC Study)
Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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hours to determine aldosterone in the urine sample after medications interfering in aldosterone release are temporarily withdrawn.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 14 Dec 2024
- Start date
- 22 Oct 2024
- Primary completion date
- 31 May 2026
- Lead sponsor
- Medical University of Gdansk
- Diseases
- High blood pressure
- NCT number
- NCT06740838
What you commit to
- Study type: Observational
- Planned participants: 240
- From 22 Oct 2024 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- therapy with glucocorticoids, non-steroidal anti-inflammatory drugs, hormonal replacement therapy, hormonal contraceptive therapy, and/or licorice intake,
Lab values
- 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.
Other
- 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),
- established or suspected secondary HT other than due to PA,
Who the study is looking for
- 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.
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology and Internal Medicine, University Clinical Center, Medical University of Gdansk Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
Related publications
- Overnight Dexamethasone in Primary Aldosteronism Screening in Patients on Interfering Therapy (ODEPRASC): A Diagnostic Interpretability Study Protocol.J Clin Hypertens (Greenwich) · 2025 · PMID 41268804
This page is information, not medical advice. Discuss any trial with your doctor.