UnknownNot Applicable

Rapid Cortisol Assay in Adrenal Vein Sampling

200 participantsStarted 2018-04-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: According to current guidelines consecutive patients with biochemical diagnosis of PA, who seek surgical cure of PA will be recruited for this study.These patients have a compelling indication to AVS before being referred or not for adrenalectomy. \- Exclusion Criteria: i) refusal of the center's to participate in the study; ii)refusal of the patientto undergo AVS and/or contraindications to the general anesthesia that is required for laparoscopic adrenalectomy; iii) cortisol -and aldosterone co-secreting adenoma. \-

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of selectivity of the sample

Timeframe: two years

Trial details

NCT IDNCT03449797

SponsorUniversity Hospital Padova

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-31

View on ClinicalTrials.gov More Primary Aldosteronism Due to Aldosterone Producing Adenoma trials