Overnight Dexamethasone in Primary Aldosteronism Screening

Launched by MEDICAL UNIVERSITY OF GDANSK · Dec 14, 2024

Keywords

ClinConnect Summary

The ODEPRASC Study is a clinical trial designed to see if a specific test can help improve the screening for primary aldosteronism, a condition that can cause high blood pressure due to too much of a hormone called aldosterone. In this study, participants will take a small dose of a medication called dexamethasone before undergoing hormone tests. This medication is commonly used to help doctors assess adrenal gland issues. The goal is to determine if taking dexamethasone overnight can help identify patients who may have primary aldosteronism more effectively, especially those already on blood pressure medications.

To be eligible for this study, participants should be between 40 and 75 years old and have high blood pressure or be suspected of having it. They must also have specific hormone test results available and be scheduled for the dexamethasone test. Those who participate will need to make some temporary changes to their medications to ensure accurate test results. They can expect to take the dexamethasone test one to three times and provide urine samples for analysis. This study will help doctors understand better how to identify primary aldosteronism, potentially leading to more effective treatments for patients with this condition.

Gender

ALL

Eligibility criteria

• 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.