Renal Cysts and Primary Aldosteronism

Tampere University Hospital115 enrolled

Overview

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.

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

115

Conditions

Primary Aldosteronism

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed primary aldosteronism according to Endocrine Society guidelines * Adrenal vein sampling performed in Tampere University Hospital * Informed consent Exclusion Criteria: \-

Locations (1)

Tampere University Hospital

Tampere, Finland

Outcomes

Primary Outcomes

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

Time frame: Baseline

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)

Renin concentration difference (mU/L)

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)

Renin activity difference (ng of Ang I/ml/h)

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)

Concentration difference (mU/l)

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)

Activity difference (ng of Ang I/ml/h)

Time frame: During procedure

Prevalence (%) of renal cysts in patients in computed tomography with contrast media

Prevalence of cysts

Time frame: 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

Data from ClinicalTrials.gov

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