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

Primary Purpose

Primary Aldosteronism

Status
Unknown status
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
Synacthen infusion during adrenal venous sampling
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Primary Aldosteronism focused on measuring primary aldosteronism, adrenal adenoma, arterial hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed primary aldosteronism

Exclusion Criteria: Inability to undergo unilateral adrenalectomy

Sites / Locations

  • University Hospital Hradec KraloveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Synacthen

Without Synacthen

Arm Description

Synacthen infusion during adrenal venous sampling

Adrenal venous sampling without Synacthen

Outcomes

Primary Outcome Measures

To verify whether Synacthen infusion may influence the results of adrenal venous sampling in patients with primary aldosteronism

Secondary Outcome Measures

Full Information

First Posted
April 25, 2014
Last Updated
April 28, 2014
Sponsor
Charles University, Czech Republic
Collaborators
University Hospital Hradec Kralove
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1. Study Identification

Unique Protocol Identification Number
NCT02127840
Brief Title
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
Acronym
ISIRA
Official Title
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
Collaborators
University Hospital Hradec Kralove

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The project is aimed to determine the value of synacthen infusion on the results of adrenal venous sampling in patients examined for primary aldosteronism
Detailed Description
We aim to compare the results of adrenal venous sampling performed without and during synacthen infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism
Keywords
primary aldosteronism, adrenal adenoma, arterial hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Synacthen
Arm Type
Experimental
Arm Description
Synacthen infusion during adrenal venous sampling
Arm Title
Without Synacthen
Arm Type
No Intervention
Arm Description
Adrenal venous sampling without Synacthen
Intervention Type
Drug
Intervention Name(s)
Synacthen infusion during adrenal venous sampling
Intervention Description
Adrenal venous sampling during Synacthen infusion
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed primary aldosteronism Exclusion Criteria: Inability to undergo unilateral adrenalectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miroslav Solar, MD
Phone
+420495834739
Email
miroslav.solar@fnhk.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Jiri Ceral, MD
Phone
+420495833249
Email
ceral.jiri@fnhk.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiri Ceral, MD
Organizational Affiliation
University Hospital Hradec Kralove
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miroslav Solar, MD
Phone
+420495834739
Email
miroslav.solar@fnhk.cz

12. IPD Sharing Statement

Learn more about this trial

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

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