Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism
- Conditions
- Primary AldosteronismHypercortisolismMineralocorticoid Excess
- Interventions
- Device: dynamic microdialysis sampling
- Registration Number
- NCT06495983
- Lead Sponsor
- Haukeland University Hospital
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Primary aldosteronism dynamic microdialysis sampling Patients with suspected and/or confirmed primary aldosteronism, aged 18-70 years
- Primary Outcome Measures
Name Time Method Multisteroid rhythmicity of mineralocorticoids and glucocorticoids in primary aldosteronism 2024-2028 Assess multisteroid rhythmicity measured 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 Outcome Measures
Name Time Method cortisol co-secretion in primary aldosteronism 2024-2028 determine and quantify the presence of cortisol co-secretion in primary aldosteronism assessed by dynamic microdialysis compared with conventional cortisol co-secretion testing
Effect of saline infusion test on multisteroid rhythmicity of mineralocorticoids and glucocorticoids 2024-2028 Influence of diagnostic saline infusion test on multisteroid adrenal rhythmicity will be assessed by performing 24h microdialysis before and during saling infusion testing
Effect of exogenous glucocorticoid suppression on aldosterone rhythmicity 2024-2028 Influence of exogenous administered glucocorticoids on aldosterone and related adrenal hormone rhythmicity will be assessed by performing 24h microdilays without and during suppression with exogenous glucocorticoids
Blood pressure, glucose and sleeep pattern correlation to dynamic hormone rhythmicity in primary aldosteronism 2024-2028 Correlate continous blood pressure and glucose variations, sleep, food intake and movement to variations in multisteroid hormone rhythmicity in primary aldosteronism.
Trial Locations
- Locations (1)
Haukeland University Hospital
🇳🇴Bergen, Norway