A multicentre PROspective study on the diagnostic value of Steroid profiling in primary ALDOsteronism: The PROSALDO study

Not Applicable

Recruiting

Conditions: E26.0
Primary hyperaldosteronism

Registration Number: DRKS00017084

Lead Sponsor: Medizinische Klinik und Poliklinik IV, Klinikum der Universität, LMU München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1500

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

• 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the predictive value of peripheral venous plasma steroids for the diagnosis and subtyping of primary aldosteronism

Secondary Outcome Measures

Name	Time	Method
-Determine the value of adrenal venous plasma steroids for the differentiation of unilateral and bilateral forms of primary aldosteronism<br><br>-Establish any advantage of LC-MS/MS measurements of peripheral venous angiotensin peptides over measurements of renin<br><br>-Establish utility of LC-MS/MS based measurements of aldosterone as end-point markers of the saline infusion test<br><br>-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.