An observational study in Primary Aldosteronism, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Tampere University Hospital · Observational
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.
193 studies on the registry are indexed under Hyperaldosteronism; 89 are open to participants now.
This study's enrollment of 115 is below the median of 200 across 98 observational studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with confirmed primary aldosteronism undergoing subtyping by adrenal vein sampling
Exclusion Criteria:
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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
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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: During procedure
Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cysts
Concentration difference
Time frame: 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
Time frame: During procedure
Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cysts
Activity difference
Time frame: 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
Time frame: Baseline
Plan to share: Undecided — IPD may not be shareable according to local laws and regulations
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Tampere University Hospital