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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017084
Enrollment
1500
Registered
2020-01-17
Start date
2019-04-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E26.0

Interventions

Group 1: Steroid Profile measured with LCMS to diagnose primary aldosteronismus

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

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

MeasureTime frame
Determine the predictive value of peripheral venous plasma steroids for the diagnosis and subtyping of primary aldosteronism

Secondary

MeasureTime 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

Public ContactNina Nirschl

Medizinische Klinik IV, LMU München

Nina.Nirschl@med.uni-muenchen.de+49 89 4400 52317

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026