Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dynamic microdialysis sampling.
- Who it may be relevant to
- Registry conditions: Mineralocorticoid Excess, Primary Aldosteronism, Hypercortisolism. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study is a observational study applying 24-hour microdialysis methodology to perform dynamic multisteroid adrenal hormone profiling of patients with suspected or confirmed PA. Simultaneous registration of blood pressure, tissue glucose, sleep pattern, activity level and food intake registration may be performed. The overall objective is to develop a novel, sensitive, fast and user-friendly diagnostic procedure for PA, using multimodal data capture including dynamic multisteroid hormone profiling from microdialysis fluid.
Detailed description
Primary aldosteronism is the most common cause of secondary hypertension. Primary aldosteronism has increased risk of organ complications compared with primary hypertension if left undiagnosed and without specific treatment. However, the current diagnostic work-up is a cumbersome, multistep process, relying on repeated single time point measurements of aldosterone, not capturing the rhythmic nature of aldosterone and related adrenal hormone secretion.
In this study we will apply the U-Rhythm microdialysis sampling system for 24-hour measurements from subcutaneous microdialysis fluid, analysed with LC/MS-MS methodology for dynamic multisteroid adrenal hormone profiling. We will further compare multisteroid hormone profiling results with variations in blood pressure and tissue glucose, sleep pattern, activity level and food intake.
The overall objective of the study is to develop a novel, sensitive, fast and user-friendly diagnostic procedure for PA, using multimodal data capture including 24-hour dynamic multisteroid hormone profiling from microdialysis tissue.
Primary objective
• Assess dynamic multisteroid rhythmicity in microdialysis fluid of aldosterone, precursors and metabolites of the mineralocorticoid and glucocorticoid pathway, compared to standard diagnostic work-up in patients with suspected or confirmed PA.
Secondary objectives
* Quantify the influence of salt and volume loading during diagnostic saline infusion test on multisteroid adrenal rhythmicity. * Quantify the influence of glucocorticoids/ACTH suppression on multisteroid rhythmicity. * Quantify the influence of cortisol co-secretion on multisteroid rhythmicity in PA. * Quantify influence of blood pressure, pulse, sleep, food intake and movement on multisteroid rhythmicity in PA.
Interventions
- Device dynamic microdialysis sampling
Included patients will perform 24-hour dynamic microdialysis sampling from subcutaneous tissue fluid of the lower abdomen, applying the U-Rhythm sampler. Simutaneous measurements of blood pressure, glucose, and registration of activity level, meals and sleep pattern during microdialysis sampling may be performed. Microdialysis sampling will be performed during various conditions: during daily life activities, during saline infusion suppression testing and during dexamethasone suppression testing
Primary outcome measures
- Multisteroid rhythmicity of mineralocorticoids and glucocorticoids in primary aldosteronism [Time frame: 2024-2028]
Secondary outcome measures (4)
- Effect of saline infusion test on multisteroid rhythmicity of mineralocorticoids and glucocorticoids [Time frame: 2024-2028]
- Effect of exogenous glucocorticoid suppression on aldosterone rhythmicity [Time frame: 2024-2028]
- cortisol co-secretion in primary aldosteronism [Time frame: 2024-2028]
- Blood pressure, glucose and sleeep pattern correlation to dynamic hormone rhythmicity in primary aldosteronism [Time frame: 2024-2028]
Eligibility criteria
Inclusion criteria Age 18 to 70 years Suspected PA admitted for diagnostic saline infusion testing or confirmed PA diagnosis according to Endocrine Society criteria.. Written informed consent
Exclusion criteria
- Age <18 or > 70 years.
- Pregnancy.
- Known adrenal failure and/or on steroid therapy (oral, inhaled, parenteral or topical) or other interfering medication.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- Haukeland University Hospital — Bergen
Identifiers
NCT: NCT06495983 · REK 729178