E26.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Male and female adult patients (18-70 yr) with hypertension who are suspected to have PA and in whom other causes of secondary hypertension have been excluded according to standard clinical criteria • All subjects must have read, understood and signed the informed consent form before inclusion into the study protocol
Exclusion criteria
Exclusion criteria: • Patients with other forms of secondary hypertension • Subjects who need medications that may interfere with or invalidate outcome parameters (e.g., steroids, oral contraceptives) • Patients with low or low-normal aldosterone (basal aldosterone <6.1 ng/dl) (<170 pmol/l) • Pregnancy • Patients with impaired mental capacity that precludes informed consent • Patients at risk of allergic reaction to contrast media • Unsuitability for or objection to undergo AVS, CT or adrenal surgery • Severe or terminal co-morbidity which seriously interferes with possible treatment or health related quality of life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the predictive value of peripheral venous plasma steroids for the diagnosis and subtyping of primary aldosteronism | — |
Secondary
| Measure | Time frame |
|---|---|
| -Determine the value of adrenal venous plasma steroids for the differentiation of unilateral and bilateral forms of primary aldosteronism -Establish any advantage of LC-MS/MS measurements of peripheral venous angiotensin peptides over measurements of renin -Establish utility of LC-MS/MS based measurements of aldosterone as end-point markers of the saline infusion test -To compare the current screening (plasma aldosterone/renin ratio) and confirmation methods with the reference standard of 24-hr urinary aldosterone excretion for the diagnosis of PA. | — |
Countries
Australia, Austria, Germany, Italy, Poland, Switzerland
Contacts
Medizinische Klinik IV, LMU München