Ignite Creation Date:
2024-07-17 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495983
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 LCMS-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 glucocorticoidsACTH 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
In this study we will apply the U-Rhythm microdialysis sampling system for 24-hour measurements from subcutaneous microdialysis fluid analysed with LCMS-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 glucocorticoidsACTH 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None