Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism

NCT06495983 | Recruiting

• 1 other identifier: REK 729178
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mineralocorticoid Excess; Primary Aldosteronism; Hypercortisolism

Keywords

aldosterone

Outcome Measures

Primary Outcomes (1)

• Multisteroid rhythmicity of mineralocorticoids and glucocorticoids in primary aldosteronism

  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.

  2024-2028

Secondary Outcomes (4)

• Effect of saline infusion test on multisteroid rhythmicity of mineralocorticoids and glucocorticoids

  2024-2028

• Effect of exogenous glucocorticoid suppression on aldosterone rhythmicity

  2024-2028

• cortisol co-secretion in primary aldosteronism

  2024-2028

• Blood pressure, glucose and sleeep pattern correlation to dynamic hormone rhythmicity in primary aldosteronism

  2024-2028

Study Arms (1)

Primary aldosteronism

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

Device: dynamic microdialysis sampling

Interventions

dynamic microdialysis sampling 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.

Primary aldosteronism

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with suspected primary aldosteronism admitted to Haukeland University for diagnostic saline infusion test will be invited for study inclusion for dynamic microdialysis during saline infusion testing. If the diagnosis is confirmed, a repeated microdialysis sampling will be performed without saline infusion suppression. Additional patients with confirmed primary aldosteronism admitted to Haukeland University Hospital for subtyping with adrenal vein sampling will be invited for study inclusion for microdialysis without and during dexamethasone suppression.

You may not qualify if:

• Age \<18 or \> 70 years.
• Pregnancy.
• Known adrenal failure and/or on steroid therapy (oral, inhaled, parenteral or topical) or other interfering medication.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

data from microdialysis fluid, blood and urine will be collected

MeSH Terms

Conditions

Hyperaldosteronism; Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Marianne Aarda Grytaas, MD PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Aardal Grytaas, MD PhD

CONTACT

004741545435; marianne.grytaas@helse-bergen.no

Kristian Løvås, MD PhD

CONTACT

004791113955; kristian.lovas@helse-bergen.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

NO (1)