Primary AldosteronismNCT05435703
Renal Cysts and Primary Aldosteronism
An observational study of Primary Aldosteronism, run by Tampere University Hospital at 1 site in Finland.
Trial summary
During routine subtyping of confirmed primary aldosteronism by adrenal vein sampling extra plasma samples are drawn from both renal veins and from inferior vena cava. Plasma renin concentration and renin activity are analysed from these samples. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism
- How many people
- 115 participants
- Where
- 1 siteFinland
- Study dates
- 7 Oct 2020to 30 Dec 2021
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with confirmed primary aldosteronism undergoing subtyping by adrenal vein sampling
Who may be able to join
- Confirmed primary aldosteronism according to Endocrine Society guidelines
- Adrenal vein sampling performed in Tampere University Hospital
- Informed consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Renal Cysts on Laboratory Diagnostics of Primary Aldosteronism
During routine subtyping of confirmed primary aldosteronism by adrenal vein sampling extra plasma samples are drawn from both renal veins and from inferior vena cava. Plasma renin concentration and renin activity are analysed from these samples. Adrenal computed tomographies are analysed for cysts and other possible pathology by a blinded radiologist. Aim is to evaluate correlation between renal pathology and renin measurements.
Read the detailed description
Aim of the study is to evaluate the prevalence of renal cysts and their association with renin concentrationand acitivity in samples from renal veins and inferior vena cava (IVC) in patients who undergo an adrenal vein sampling (AVS) because of primary aldosteronism.
In a prospective study up to 200 patients who have been referred to Tampere University Hospital for AVS are recruited during 24 months. Informed consent is taken. Clinical, medication, radiological and laboratory information according to Endcrine Society guidelines is collected. Interventional radiologist will draw venous blood from both renal veins and from IVC for later renin analyses. One, blinded radiologist will record renal pathology of cysts but also other abnormal radiologic features.
An interim analysis will be done when 60-100 patients have been recruited or at 6-12 months from the start of the study. Study will be stopped if significant difference can be found in renin measurement in patients with renal cysts compared with patients without renal cysts.
- Conditions
- Primary Aldosteronism
- Keywords
- Adrenal vein sampling, Renal cysts, Renin concentration, Renin activity
- Medical subject headings
- Hyperaldosteronism
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of any renal cyst finding to graded baseline renin concentration (mU/L)
Number of patients with renal cysts when renin concentration (mU/L) is low, low normal or high normal to high
Measured: Baseline
Secondary outcomes (14)
Correlation of renin concentration (mU/L) in inferior vena cava in all patients and in patients with or without renal cysts (or other renal pathology)
Renin concentration difference (mU/L)
Measured: During procedure
Correlation of renin activity (ng of Ang I/ml/h) in inferior vena cava in all patients and in patients with or without renal cysts (or other renal pathology)
Renin activity difference (ng of Ang I/ml/h)
Measured: During procedure
Correlation of renin concentration (mU/l) in right and left renal vein from the side with or without renal cysts (or other renal pathology)
Concentration difference (mU/l)
Measured: During procedure
Correlation of renin activity (ng of Ang I/ml/h) in right and left renal vein from the side with or without renal cysts (or other renal pathology)
Activity difference (ng of Ang I/ml/h)
Measured: During procedure
Prevalence (%) of renal cysts in patients in computed tomography with contrast media
Prevalence of cysts
Measured: Baseline
Association of prevalence of renal cysts (%) with severity of hypertension
Percentage of patients with renal cysts when patients are grouped according to quartiles of severity of hypertension
Measured: Baseline
Association of prevalence of renal cysts (%) with duration (years) of hypertension
Percentage of patients with renal cysts when patients are grouped according to quartiles of duration of hypertension (years)
Measured: Baseline
Association of prevalence of renal cysts (%) with plasma potassium concentration (mmol/l)
Percentage of patients with renal cysts (%) when patients are grouped according to quartiles of lowest plasma potassium
Measured: Baseline
Association of prevalence of renal cysts (%) with severity of primary aldosteronism
Percentage of patients with renal cysts when patients are grouped according to quartiles of aldosterone to renin ratio (pmol/L)/(mU/L)
Measured: Baseline
Renin concentration (mU/l) in renal veins on the side of renal cysts compared with the side with no cysts of each kidney
Concentration difference
Measured: During procedure
Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cysts
Concentration difference
Measured: During procedure
Renin activity (ng of Ang I/ml/h) in renal veins on the side of renal cysts compared with the side with no cysts
Activity difference
Measured: During procedure
Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cysts
Activity difference
Measured: During procedure
Association of renal cyst finding to baseline renin concentration (mU/l) in different age groups
Number of patients with renal cysts when renin concentration is low, low normal or high normal to high
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start7 Oct 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, Tampere University
- Responsible party
- Sponsor
- Investigators
- Pasi I Nevalainen, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435703
- Sponsor's protocol ID
- R20023
- Status last verified
- Jan 2023
- First submitted
- 30 Apr 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may not be shareable according to local laws and regulations
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Renal Cysts on Laboratory Diagnostics of Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT05435703
- Acronym / sponsor ID
- R20023
- Conditions
- Primary Aldosteronism
- Keywords
- Adrenal vein sampling, Renal cysts, Renin concentration, Renin activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, Tampere University
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 28 Jun 2022 (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.
During routine subtyping of confirmed primary aldosteronism by adrenal vein sampling extra plasma samples are drawn from both renal veins and from inferior vena cava. Plasma renin concentration and renin activity are analysed from these samples. Adrenal computed tomographies are analysed for cysts and other possible pathology by a blinded radiologist. Aim is to evaluate correlation between renal pathology and renin measurements.
Detailed description
Aim of the study is to evaluate the prevalence of renal cysts and their association with renin concentrationand acitivity in samples from renal veins and inferior vena cava (IVC) in patients who undergo an adrenal vein sampling (AVS) because of primary aldosteronism.
In a prospective study up to 200 patients who have been referred to Tampere University Hospital for AVS are recruited during 24 months. Informed consent is taken. Clinical, medication, radiological and laboratory information according to Endcrine Society guidelines is collected. Interventional radiologist will draw venous blood from both renal veins and from IVC for later renin analyses. One, blinded radiologist will record renal pathology of cysts but also other abnormal radiologic features.
An interim analysis will be done when 60-100 patients have been recruited or at 6-12 months from the start of the study. Study will be stopped if significant difference can be found in renin measurement in patients with renal cysts compared with patients without renal cysts.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with confirmed primary aldosteronism undergoing subtyping by adrenal vein sampling
Key inclusion criteria (3 listed)
- Confirmed primary aldosteronism according to Endocrine Society guidelines
- Adrenal vein sampling performed in Tampere University Hospital
- Informed consent
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of any renal cyst finding to graded baseline renin concentration (mU/L)
Time frame: Baseline
Number of patients with renal cysts when renin concentration (mU/L) is low, low normal or high normal to high
14 secondary outcomes
Correlation of renin concentration (mU/L) in inferior vena cava in all patients and in patients with or without renal cysts (or other renal pathology)
Time frame: During procedure
Correlation of renin activity (ng of Ang I/ml/h) in inferior vena cava in all patients and in patients with or without renal cysts (or other renal pathology)
Time frame: During procedure
Correlation of renin concentration (mU/l) in right and left renal vein from the side with or without renal cysts (or other renal pathology)
Time frame: During procedure
Correlation of renin activity (ng of Ang I/ml/h) in right and left renal vein from the side with or without renal cysts (or other renal pathology)
Time frame: During procedure
Prevalence (%) of renal cysts in patients in computed tomography with contrast media
Time frame: Baseline
Association of prevalence of renal cysts (%) with severity of hypertension
Time frame: Baseline
Association of prevalence of renal cysts (%) with duration (years) of hypertension
Time frame: Baseline
Association of prevalence of renal cysts (%) with plasma potassium concentration (mmol/l)
Time frame: Baseline
Association of prevalence of renal cysts (%) with severity of primary aldosteronism
Time frame: Baseline
Renin concentration (mU/l) in renal veins on the side of renal cysts compared with the side with no cysts of each kidney
Time frame: During procedure
Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cysts
Time frame: During procedure
Renin activity (ng of Ang I/ml/h) in renal veins on the side of renal cysts compared with the side with no cysts
Time frame: During procedure
Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cysts
Time frame: During procedure
Association of renal cyst finding to baseline renin concentration (mU/l) in different age groups
Time frame: Baseline
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 5 Jan 2023.
- Individual participant dataSharing planned: Undecided. IPD may not be shareable according to local laws and regulations
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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. This study is not recruiting at the moment.
Pasi I Nevalainen, MD, PhD principal investigator
Tampere 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 Primary Aldosteronism, run by Tampere University Hospital at 1 site in Finland.
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 1 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 5 Jan 2023. 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 Finland. 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?
Association of any renal cyst finding to graded baseline renin concentration (mU/L) (time frame: Baseline). 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 5 Jan 2023.