Skip to main content
OpenTrials
Completed

NCT Number: NCT05435703

Renal Cysts and 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere University Hospital

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Association of any renal cyst finding to graded baseline renin concentration (mU/L)

    Time frame: Baseline

    Number of patients with renal cysts when renin concentration (mU/L) is low, low normal or high normal to high

Secondary outcomes

  1. 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)

    Time frame: During procedure

    Renin concentration difference (mU/L)

  2. 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)

    Time frame: During procedure

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

  3. Correlation of renin concentration (mU/l) in right and left renal vein from the side with or without renal cysts (or other renal pathology)

    Time frame: During procedure

    Concentration difference (mU/l)

  4. 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)

    Time frame: During procedure

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

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

    Time frame: Baseline

    Prevalence of cysts

  6. Association of prevalence of renal cysts (%) with severity of hypertension

    Time frame: Baseline

    Percentage of patients with renal cysts when patients are grouped according to quartiles of severity of hypertension

  7. Association of prevalence of renal cysts (%) with duration (years) of hypertension

    Time frame: Baseline

    Percentage of patients with renal cysts when patients are grouped according to quartiles of duration of hypertension (years)

  8. Association of prevalence of renal cysts (%) with plasma potassium concentration (mmol/l)

    Time frame: Baseline

    Percentage of patients with renal cysts (%) when patients are grouped according to quartiles of lowest plasma potassium

  9. Association of prevalence of renal cysts (%) with severity of primary aldosteronism

    Time frame: Baseline

    Percentage of patients with renal cysts when patients are grouped according to quartiles of aldosterone to renin ratio (pmol/L)/(mU/L)

  10. Renin concentration (mU/l) in renal veins on the side of renal cysts compared with the side with no cysts of each kidney

    Time frame: During procedure

    Concentration difference

  11. Renin concentration (mU/l) in inferior vena cava in patients with renal cysts compared with patients with no cysts

    Time frame: During procedure

    Concentration difference

  12. Renin activity (ng of Ang I/ml/h) in renal veins on the side of renal cysts compared with the side with no cysts

    Time frame: During procedure

    Activity difference

  13. Renin activity (ng of Ang I/ml/h) in inferior vena cava in patients with renal cysts

    Time frame: During procedure

    Activity difference

  14. Association of renal cyst finding to baseline renin concentration (mU/l) in different age groups

    Time frame: Baseline

    Number of patients with renal cysts when renin concentration is low, low normal or high normal to high

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Helsinki University Central Hospital
  • Kuopio University Hospital
  • Tampere University

Registry information

Official study title

The Effect of Renal Cysts on Laboratory Diagnostics of Primary Aldosteronism

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2022
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.