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Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism

ConditionsMineralocorticoid ExcessPrimary AldosteronismHypercortisolism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorHaukeland University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Age <18 or > 70 years.

Pregnancy.

Known adrenal failure and/or on steroid therapy (oral, inhaled, parenteral or topical) or other interfering medication.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Primary aldosteronism1 intervention

Trial outcomes

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.

Time frame
2024-2028

Secondary outcomes

1

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

Influence of diagnostic saline infusion test on multisteroid adrenal rhythmicity will be assessed by performing 24h microdialysis before and during saling infusion testing

Time frame
2024-2028
2

Effect of exogenous glucocorticoid suppression on aldosterone rhythmicity

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

Time frame
2024-2028
3

cortisol co-secretion in primary aldosteronism

determine and quantify the presence of cortisol co-secretion in primary aldosteronism assessed by dynamic microdialysis compared with conventional cortisol co-secretion testing

Time frame
2024-2028
4

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

Correlate continous blood pressure and glucose variations, sleep, food intake and movement to variations in multisteroid hormone rhythmicity in primary aldosteronism.

Time frame
2024-2028

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haukeland University Hospital

Lead sponsor

University of Bergen

Collaborator

Source ClinicalTrials.gov
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