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hours to determine aldosterone in the urine sample after medications interfering in aldosterone release are temporarily withdrawn.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
This trial does not accept healthy volunteersQualifiers
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 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
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
240 Participants
are grouped into 2 trial groupsGroup A: Post-DXM ARR development cohort
Group B: Post-DXM ARR confirmatory cohort
Trial outcomes
Primary outcomes
1
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
Time frame
24 monthsSecondary 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.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov