Renal Cysts and Primary Aldosteronism

Primary Aldosteronism Clinical Trial

Official title:

The Effect of Renal Cysts on Laboratory Diagnostics of Primary Aldosteronism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435703
• Other study ID #: R20023
• Status: Completed
• Start date: October 7, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Confirmed primary aldosteronism according to Endocrine Society guidelines

• Adrenal vein sampling performed in Tampere University Hospital

• Informed consent

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (4)

Lead Sponsor	Collaborator
Tampere University Hospital	Helsinki University Central Hospital, Kuopio University Hospital, Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

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