An observational study in Mineralocorticoid Excess, Primary Aldosteronism and Hypercortisolism, sponsored by Haukeland University Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Haukeland University Hospital · Observational
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.
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
Secondary objectives
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 80 is below the median of 200 across 103 observational studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion criteria Age 18 to 70 years Suspected PA admitted for diagnostic saline infusion testing or confirmed PA diagnosis according to Endocrine Society criteria.. Written
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with suspected and/or confirmed primary aldosteronism, aged 18-70 years
Device: 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.
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
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
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
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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Dec 2028, 54 months after the start.
Of 64 non-industry observational studies under Hyperaldosteronism, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 96. This study's planned 54 months is below that.
Counting every sponsor, half of 64 studies reached it within 75 months; a quarter within 32 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Haukeland University Hospital →