Improving screening for primary aldosteronism in patients with hypertension
Overnight Dexamethasone in Primary Aldosteronism Screening in Patients on Interfering Therapy (the ODEPRASC Study)
This study is testing if giving a small dose of dexamethasone can help doctors better identify primary aldosteronism in patients with high blood pressure who are already on medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of Gdansk Academic / other |
| Locations | 1 site (Gdansk, Pomeranian Voivodeship) |
| Trial ID | NCT06740838 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40 to 75 with suspected or diagnosed hypertension and available aldosterone and renin results.
Not a fit: Patients with baseline hyperreninemia, adrenal hormone deficiencies, or those on certain medications that interfere with the study's outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification and treatment of primary aldosteronism, potentially improving blood pressure management for affected patients.
How similar studies have performed: Previous studies have shown that incorporating ACTH suppression can improve diagnostic efficacy for primary aldosteronism, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gdansk, Pomeranian Voivodeship
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.