Primary HyperaldosteronismNCT01761344
Intraoperative Analysis of Cortisol During Adrenal Vein Sampling
A study testing Intraoperative cortisol measurement. in people with Primary Hyperaldosteronism, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperaldosteronism
- What is being tested?
- Intraoperative cortisol measurement.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hyperaldosteronism
- Motivated for surgery if applicable
- Able to give informed consent
Who cannot join
- Not able to give informed consent
- Severe kidney failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.
Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary hypertension. The overproduction of aldosteron might in some cases be due to unilateral hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. In these cases the adrenal can be removed and the patient cured of hypertension. The clinical evaluation of patients with confirmed primary hyperaldosteronism therefore includes selective sampling of blood from the adrenal veins to determine lateralization of overproduction. This is executed as an interventional radiological procedure.
The adrenal vein sampling is challenging, and success is determined by measuring another adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample. By routine laboratory assays the procedure is evaluated after the patient has been discharged from the hospital. In the study a rapid assay of cortisol will be evaluated, allowing the radiologist to draw new samples during the same procedure if the first set of samples is unsuccessful. The study hypothesis is that intraoperative measurement of cortisol is a useful tool to evaluate successful sampling, and that fewer patients will need a repeated procedure.
- Conditions
- Primary Hyperaldosteronism
- Being tested
- Intraoperative cortisol measurement.
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative cortisol measurement.Other
Levels of cortisol in blood samples will be determined using a rapid cortisol assay. This is not standard procedure
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative measurement of cortisol | Experimental | Intervention: During a routine procedure intraoperative cortisol is measured. Upon unsuccessful sampling, the sampling will be repeated. Receives: Other: Intraoperative cortisol measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Representative blood sample from adrenal veins bilaterally.
Patients where the drawn blood from both adrenal veins is representative is the primary endpoint.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Mellgren, MD.PhD, Study chair, Hormonlaboratoriet, Haukeland Universitetssykehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761344
- Sponsor's protocol ID
- 2012/1856
- Status last verified
- Aug 2013
- First submitted
- 2 Jan 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Analysis of Cortisol During Adrenal Vein Catheterization and Sampling in Patients With Primary Hyperaldosteronism.
- ClinicalTrials.gov ID
- NCT01761344
- Acronym / sponsor ID
- 2012/1856
- Conditions
- Primary Hyperaldosteronism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Jan 2013 (estimated)
- 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.
Aldosterone is a hormone produced in the adrenals that helps regulate the salt balance and blood pressure. Primary hyperaldosteronism is one of the main endocrine causes of secondary hypertension. The overproduction of aldosteron might in some cases be due to unilateral hyperplasia of the adrenal cortex or a unilateral aldosterone-producing adenoma. In these cases the adrenal can be removed and the patient cured of hypertension. The clinical evaluation of patients with confirmed primary hyperaldosteronism therefore includes selective sampling of blood from the adrenal veins to determine lateralization of overproduction. This is executed as an interventional radiological procedure.
The adrenal vein sampling is challenging, and success is determined by measuring another adrenal hormone named cortisol in the blood samples as a marker of a correctly drawn sample. By routine laboratory assays the procedure is evaluated after the patient has been discharged from the hospital. In the study a rapid assay of cortisol will be evaluated, allowing the radiologist to draw new samples during the same procedure if the first set of samples is unsuccessful. The study hypothesis is that intraoperative measurement of cortisol is a useful tool to evaluate successful sampling, and that fewer patients will need a repeated procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative measurement of cortisol | Experimental | Other: Intraoperative cortisol measurement.Intervention: During a routine procedure intraoperative cortisol is measured. Upon unsuccessful sampling, the sampling will be repeated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary hyperaldosteronism
- Motivated for surgery if applicable
- Able to give informed consent
Key exclusion criteria (2 listed)
- Not able to give informed consent
- Severe kidney failure
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 |
|---|---|---|
| Intraoperative cortisol measurement.Levels of cortisol in blood samples will be determined using a rapid cortisol assay. This is not standard procedure | Other | Intraoperative measurement of cortisol |
Primary outcome
Representative blood sample from adrenal veins bilaterally.
Time frame: Intraoperatively
Patients where the drawn blood from both adrenal veins is representative is the primary endpoint.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
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Primary Aldosteronism
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. This study is not recruiting at the moment.
Gunnar Mellgren, MD.PhD study chair
Hormonlaboratoriet, Haukeland Universitetssykehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative cortisol measurement. in people with Primary Hyperaldosteronism, 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 29 Aug 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Representative blood sample from adrenal veins bilaterally. (time frame: Intraoperatively). 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 29 Aug 2013.