Renal Cysts and Primary Aldosteronism

Completed

• Conditions: Primary Aldosteronism

• Registration Number: NCT05435703
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study Start: 2020-10-07
• Study First Submitted: 2021-04-30
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association of any renal cyst finding to graded baseline renin concentration (mU/L)	Baseline	Number of patients with renal cysts when renin concentration (mU/L) is low, low normal or high normal to high

Secondary Outcome Measures

Name	Time	Method
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 procedure	Activity difference (ng of Ang I/ml/h)
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 procedure	Renin concentration difference (mU/L)
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 procedure	Renin activity difference (ng of Ang I/ml/h)
Association of prevalence of renal cysts (%) with severity of hypertension	Baseline	Percentage 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 hypertension	Baseline	Percentage of patients with renal cysts when patients are grouped according to quartiles of duration of hypertension (years)
Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cysts	During procedure	Concentration difference
Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cysts	During procedure	Activity difference
Association of prevalence of renal cysts (%) with plasma potassium concentration (mmol/l)	Baseline	Percentage of patients with renal cysts (%) when patients are grouped according to quartiles of lowest plasma potassium
Renin activity (ng of Ang I/ml/h) in renal veins on the side of renal cysts compared with the side with no cysts	During procedure	Activity difference
Prevalence (%) of renal cysts in patients in computed tomography with contrast media	Baseline	Prevalence of cysts
Association of prevalence of renal cysts (%) with severity of primary aldosteronism	Baseline	Percentage of patients with renal cysts when patients are grouped according to quartiles of aldosterone to renin ratio (pmol/L)/(mU/L)
Association of renal cyst finding to baseline renin concentration (mU/l) in different age groups	Baseline	Number of patients with renal cysts when renin concentration is low, low normal or high normal to high
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 procedure	Concentration difference (mU/l)
Renin concentration (mU/l) in renal veins on the side of renal cysts compared with the side with no cysts of each kidney	During procedure	Concentration difference

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland