Renal Cysts and Primary Aldosteronism

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.

Study Overview

• Status: Completed
• Conditions: Primary Aldosteronism

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 Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with confirmed primary aldosteronism undergoing subtyping by adrenal vein sampling

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	During procedure
Prevalence (%) of renal cysts in patients in computed tomography with contrast media	Prevalence of cysts	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	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)	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	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)	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	During procedure
Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cysts	Concentration difference	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	During procedure
Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cysts	Activity difference	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	Baseline

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Helsinki University Central Hospital; Kuopio University Hospital; Tampere University
• Investigators: Principal Investigator: Pasi I Nevalainen, MD, PhD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Renal cysts; Adrenal vein sampling; Renin concentration; Renin activity
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism
• Other Study ID Numbers: R20023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD may not be shareable according to local laws and regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No