Mineralocorticoid ExcessNCT06495983
Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism
An observational study of Mineralocorticoid Excess and Primary Aldosteronism, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mineralocorticoid Excess, Primary Aldosteronism, Hypercortisolism
- What is being tested?
- dynamic microdialysis sampling
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Age <18 or > 70 years.
- Pregnancy.
- Known adrenal failure and/or on steroid therapy (oral, inhaled, parenteral or topical) or other interfering medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Marianne Grytaas, MD phd, +4741545435, marianne.grytaas@helse-bergen.no
Kristian Løvås, MD Phd, kristian.lovas@helse-bergen.no
About this study
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.
Read the 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.
- Being tested
- dynamic microdialysis sampling
- Keywords
- aldosterone
- Medical subject headings
- Hyperaldosteronism, Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic microdialysis samplingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary aldosteronism | Patients with suspected and/or confirmed primary aldosteronism, aged 18-70 years Receives: Device: dynamic microdialysis sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2024-2028
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 2024-2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Jun 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mineralocorticoid ExcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
- Investigators
- Marianne Aarda Grytaas, MD PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495983
- Sponsor's protocol ID
- REK 729178
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Hormone Profiling and Multimodal Data Capture in Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT06495983
- Acronym / sponsor ID
- REK 729178
- Keywords
- aldosterone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary aldosteronism | – | Device: dynamic microdialysis samplingPatients with suspected and/or confirmed primary aldosteronism, aged 18-70 years |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Age <18 or > 70 years.
- Pregnancy.
- Known adrenal failure and/or on steroid therapy (oral, inhaled, parenteral or topical) or other interfering medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic microdialysis samplingIncluded 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. | Device | Primary aldosteronism |
Primary outcome
Multisteroid rhythmicity of mineralocorticoids and glucocorticoids in primary aldosteronism
Time frame: 2024-2028
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.
4 secondary outcomes
Effect of saline infusion test on multisteroid rhythmicity of mineralocorticoids and glucocorticoids
Time frame: 2024-2028
Effect of exogenous glucocorticoid suppression on aldosterone rhythmicity
Time frame: 2024-2028
cortisol co-secretion in primary aldosteronism
Time frame: 2024-2028
Blood pressure, glucose and sleeep pattern correlation to dynamic hormone rhythmicity in primary aldosteronism
Time frame: 2024-2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marianne Aarda Grytaas, MD PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mineralocorticoid Excess and Primary Aldosteronism, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne Aardal Grytaas, MD PhD (004741545435, marianne.grytaas@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multisteroid rhythmicity of mineralocorticoids and glucocorticoids in primary aldosteronism (time frame: 2024-2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.