Actively Recruiting

Age: 40Years - 75Years
All Genders
NCT06740838

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hours to determine aldosterone in the urine sample after medications interfering in aldosterone release are temporarily withdrawn.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

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here