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Renal Cysts and Primary Aldosteronism

The Effect of Renal Cysts on Laboratory Diagnostics of Primary Aldosteronism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05435703
Enrollment
115
Registered
2022-06-28
Start date
2020-10-07
Completion date
2021-12-30
Last updated
2023-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Keywords

Adrenal vein sampling, Renal cysts, Renin concentration, Renin activity

Brief 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. 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.

Interventions

None listed

Sponsors

Helsinki University Central Hospital
CollaboratorOTHER
Kuopio University Hospital
CollaboratorOTHER
Tampere University
CollaboratorOTHER
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Confirmed primary aldosteronism according to Endocrine Society guidelines * Adrenal vein sampling performed in Tampere University Hospital * Informed consent

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Association of any renal cyst finding to graded baseline renin concentration (mU/L)BaselineNumber of patients with renal cysts when renin concentration (mU/L) is low, low normal or high normal to high

Secondary

MeasureTime frameDescription
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)During procedureRenin activity difference (ng of Ang I/ml/h)
Correlation of renin concentration (mU/l) in right and left renal vein from the side with or without renal cysts (or other renal pathology)During procedureConcentration difference (mU/l)
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)During procedureActivity difference (ng of Ang I/ml/h)
Prevalence (%) of renal cysts in patients in computed tomography with contrast mediaBaselinePrevalence of cysts
Association of prevalence of renal cysts (%) with severity of hypertensionBaselinePercentage of patients with renal cysts when patients are grouped according to quartiles of severity of hypertension
Association of prevalence of renal cysts (%) with duration (years) of hypertensionBaselinePercentage of patients with renal cysts when patients are grouped according to quartiles of duration of hypertension (years)
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)During procedureRenin concentration difference (mU/L)
Association of prevalence of renal cysts (%) with severity of primary aldosteronismBaselinePercentage of patients with renal cysts when patients are grouped according to quartiles of aldosterone to renin ratio (pmol/L)/(mU/L)
Renin concentration (mU/l) in renal veins on the side of renal cysts compared with the side with no cysts of each kidneyDuring procedureConcentration difference
Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cystsDuring procedureConcentration difference
Renin activity (ng of Ang I/ml/h) in renal veins on the side of renal cysts compared with the side with no cystsDuring procedureActivity difference
Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cystsDuring procedureActivity difference
Association of renal cyst finding to baseline renin concentration (mU/l) in different age groupsBaselineNumber of patients with renal cysts when renin concentration is low, low normal or high normal to high
Association of prevalence of renal cysts (%) with plasma potassium concentration (mmol/l)BaselinePercentage of patients with renal cysts (%) when patients are grouped according to quartiles of lowest plasma potassium

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026