NCT05435703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

1.2 years

First QC Date

April 30, 2021

Last Update Submit

January 3, 2023

Conditions

Primary Aldosteronism

Keywords

Adrenal vein samplingRenal cystsRenin concentrationRenin activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • 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)

    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)

    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)

    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)

    During procedure

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

    Baseline

  • +9 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with confirmed primary aldosteronism undergoing subtyping by adrenal vein sampling

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Pasi I Nevalainen, MD, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

June 28, 2022

Study Start

October 7, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

January 5, 2023

Record last verified: 2023-01

Locations

FI(1)