Clinical trial NCT05435703: Renal Cysts and Primary Aldosteronism
Official title: The Effect of Renal Cysts on Laboratory Diagnostics of Primary Aldosteronism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Aldosteronism
Keywords: Adrenal vein sampling
Renal cysts
Renin concentration
Renin activity
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Kuopio University Hospital
name: Tampere University
First posted: 2022-06-28
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with confirmed primary aldosteronism undergoing subtyping by adrenal vein sampling

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Association of any renal cyst finding to graded baseline renin concentration (mU/L)
timeFrame: Baseline
Secondary outcomes:
measure: 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)
timeFrame: During procedure
measure: 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)
timeFrame: During procedure
measure: Correlation of renin concentration (mU/l) in right and left renal vein from the side with or without renal cysts (or other renal pathology)
timeFrame: During procedure
measure: 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)
timeFrame: During procedure
measure: Prevalence (%) of renal cysts in patients in computed tomography with contrast media
timeFrame: Baseline
measure: Association of prevalence of renal cysts (%) with severity of hypertension
timeFrame: Baseline
measure: Association of prevalence of renal cysts (%) with duration (years) of hypertension
timeFrame: Baseline
measure: Association of prevalence of renal cysts (%) with plasma potassium concentration (mmol/l)
timeFrame: Baseline
measure: Association of prevalence of renal cysts (%) with severity of primary aldosteronism
timeFrame: Baseline
measure: Renin concentration (mU/l) in renal veins on the side of renal cysts compared with the side with no cysts of each kidney
timeFrame: During procedure
measure: Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cysts
timeFrame: During procedure
measure: Renin activity (ng of Ang I/ml/h) in renal veins on the side of renal cysts compared with the side with no cysts
timeFrame: During procedure
measure: Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cysts
timeFrame: During procedure
measure: Association of renal cyst finding to baseline renin concentration (mU/l) in different age groups
timeFrame: Baseline
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Pasi I Nevalainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: