Actively Recruiting
Overnight Dexamethasone in Primary Aldosteronism Screening
Led by Medical University of Gdansk · Updated on 2025-10-02
240
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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hours to determine aldosterone in the urine sample after medications interfering in aldosterone release are temporarily withdrawn.
CONDITIONS
Official Title
Overnight Dexamethasone in Primary Aldosteronism Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected or diagnosed hypertension
- Age between 40 and 75 years
- Available aldosterone and renin test results at the time of clinic visit
- Scheduled for a 1-mg dexamethasone test
- Presence of an adrenal lesion with features of adenoma or hyperplasia on imaging
You will not qualify if you...
- Baseline high renin levels above 46.1 mIU/l before dexamethasone
- Baseline aldosterone below 3 ng/dl before dexamethasone
- Signs of adrenal hormone imbalance other than mild autonomous cortisol secretion
- Use of glucocorticoids, non-steroidal anti-inflammatory drugs, hormonal replacement or contraceptive therapies, or licorice
- Secondary hypertension causes other than primary aldosteronism
- Poorly controlled or non-type 2 diabetes, alcohol abuse, severe obesity (BMI ≥40), serious heart disease preventing medication changes
- Active cancer, decompensated autoimmune diseases, or autoimmune diseases with heart or kidney complications
- Kidney function with eGFR below 45 ml/min/1.73m2
- Poor physical condition
- Lack of or withdrawal of consent for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Endocrinology and Internal Medicine, University Clinical Center, Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, Poland, 80214
Actively Recruiting
Research Team
P
Piotr Kmiec, M.D., Ph.D.
CONTACT
R
Renata Swiatkowska-Stodulska, Professor, MD, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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