Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism

NCT ID: NCT06495983

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2028-12-31

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.

Conditions

Mineralocorticoid Excess; Primary Aldosteronism; Hypercortisolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary aldosteronism

Patients with suspected and/or confirmed primary aldosteronism, aged 18-70 years

dynamic microdialysis sampling

Intervention Type: DEVICE

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. Repeated sampling may be performed post treatment.

Interventions

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. Repeated sampling may be performed post treatment.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Aarda Grytaas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Marianne Aardal Grytaas, MD PhD

Role: CONTACT

marianne.grytaas@helse-bergen.no

004741545435

Kristian Løvås, MD PhD

Role: CONTACT

kristian.lovas@helse-bergen.no

004791113955

Facility Contacts

Marianne Grytaas, MD phd

Role: primary

marianne.grytaas@helse-bergen.no

+4741545435

Kristian Løvås, MD Phd

Role: backup

kristian.lovas@helse-bergen.no

Other Identifiers

REK 729178

Identifier Type: -

Identifier Source: org_study_id