Overnight Dexamethasone in Primary Aldosteronism Screening

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorMedical University of Gdansk

About this trial

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to determine aldosterone in the urine sample after medications interfering in aldosterone release are temporarily withdrawn.

Eligibility criteria

Qualifiers

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),

Disqualifiers

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,

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

240 Participants
are grouped into 2 trial groups

Sponsors and collaborators