- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02127840
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 Contact
- Name: Miroslav Solar, MD
- Phone Number: +420495834739
- Email: miroslav.solar@fnhk.cz
Study Contact Backup
- Name: Jiri Ceral, MD
- Phone Number: +420495833249
- Email: ceral.jiri@fnhk.cz
Study Locations
-
-
-
Hradec Kralove, Czech Republic, 50005
- Recruiting
- University Hospital Hradec Kralove
-
Contact:
- Miroslav Solar, MD
- Phone Number: +420495834739
- Email: miroslav.solar@fnhk.cz
-
-
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
|
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.
Collaborators
Investigators
- Study Chair: Jiri Ceral, MD, University Hospital Hradec Kralove
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
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Adrenocortical Hyperfunction
- Adrenal Gland Diseases
- Hyperaldosteronism
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
- Racepinephrine
- Epinephryl borate
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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