MedTrace Logo

Rapid Cortisol Assay in Adrenal Vein Sampling

NCT03449797 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-03-09

No results posted yet for this study

Summary

Background: Adrenal vein sampling (AVS) is the gold standard test for the subtyping of primary aldosteronism (PA). This procedure is hampered by unsuccessful bilateral cannulation of adrenal veins, which can occur in up to two thirds of the cases depending on the cutoff of the selectivity index used. The rapid intra-procedural cortisol assay (IRCA) can increase the rate of bilateral success of AVS. This can be proven using a randomized prospective study design approach.

Aim: We will therefore evaluate if an IRCA-guided AVS strategy can increase the rate of selectivity and thus the success rate of adrenal vein catheterization.

Methods: Consecutive patients with a biochemical diagnosis of PA, seeking surgical cure, will be randomized to undergo AVS according to an IRCA-sham or an IRCA-guided procedure.

Experimental and endpoint will be the rate of bilaterally selective AVS studies as defined by a selective index cutoff \> 2.00 value under baseline (unstimulated) conditions. With 100 patients submitted to AVS with a normal procedure and 100 patients undergoing AVS with IRCA, it has been estimated that the study has 82% power to detect a significant difference of 18% at a two-sided 0.05 significance level between arms.

Expected results. Given this power we expect to the able to determine if IRCA is useful or not for improving the success rate of AVS. Given the current disastrous situation regarding the clinical use of AVS this will be a major accomplishment in the field of the subtyping of PA.

Conditions

  • Primary Aldosteronism Due to Aldosterone Producing Adenoma

Interventions

PROCEDURE

AVS performed with no intraprocedural rapid cortisol assay

AVS performed plus intraprocedural rapid cortisol assay

PROCEDURE

AVS performed plus intraprocedural rapid cortisol assay

Adrenal vein sampling performed according to usual clinical practice without intraprocedural rapid cortisol assay

Sponsors & Collaborators

  • University Hospital Padova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-07-31
Completion
2020-07-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449797 on ClinicalTrials.gov