Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism (ISIRA)

April 28, 2014 updated by: Miroslav Solar, Charles University, Czech Republic
The project is aimed to determine the value of synacthen infusion on the results of adrenal venous sampling in patients examined for primary aldosteronism

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We aim to compare the results of adrenal venous sampling performed without and during synacthen infusion.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 50005
        • Recruiting
        • University hospital Hradec Králové
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Confirmed primary aldosteronism

Exclusion Criteria: Inability to undergo unilateral adrenalectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Synacthen
Synacthen infusion during adrenal venous sampling
Drug: Synacthen infusion during adrenal venous sampling
Adrenal venous sampling during Synacthen infusion
No Intervention: Without Synacthen
Adrenal venous sampling without Synacthen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To verify whether Synacthen infusion may influence the results of adrenal venous sampling in patients with primary aldosteronism
Time Frame: End of clinical examination procedure, i.e. within 4 week after adrenal venous sampling is performed.
End of clinical examination procedure, i.e. within 4 week after adrenal venous sampling is performed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

University Hospital Hradec Kralove

Investigators

  • Study Chair: Jiri Ceral, MD, University hospital Hradec Králové

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 28, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAAVS1143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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