Improving screening for primary aldosteronism in patients with hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enhance the screening process for primary aldosteronism (PA) among patients on chronic blood pressure-lowering medications by administering a single 1 mg dose of dexamethasone before hormonal examinations. Primary aldosteronism is a condition characterized by excessive aldosterone production, leading to hypertension, and is often underdiagnosed. The study will evaluate whether the overnight dexamethasone test can improve diagnostic accuracy for PA in patients who are currently receiving treatment that affects the renin-angiotensin-aldosterone system. By combining established diagnostic criteria with new approaches, the study seeks to generate and validate improved screening thresholds for PA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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,
* established or suspected secondary HT other than due to PA,
* 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.

Where it's running

• Department of Endocrinology and Internal Medicine, University Clinical Center, Medical University of Gdansk
  Gdansk, Pomeranian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Piotr Kmiec, MD, Ph.D. — Department of Endocrinology and Internal Medicine, Medical University of Gdansk
• Study coordinator: Piotr Kmiec, M.D., Ph.D.
• Email: piotrkmiec@gumed.edu.pl
• Phone: 0048 585844809

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Impact of Aldosterone Blockade on Heart Function in Primary Aldosteronism

  This study is testing if a medication that blocks a hormone called aldosterone can improve heart function in people with primary aldosteronism, which causes high blood pressure.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.