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

• Sponsor: Charles University, Czech Republic (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02127840
• Collaborator: University Hospital Hradec Kralove (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 0.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Primary Aldosteronism	Drug: Synacthen infusion during adrenal venous sampling	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
• Study Start Date: Mar 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: Confirmed primary aldosteronism

Exclusion Criteria: Inability to undergo unilateral adrenalectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Kralove		Czech Republic	50005

Sponsors and Collaborators

• Charles University, Czech Republic
• University Hospital Hradec Kralove

Investigators

• Study Chair: Jiri Ceral, MD, University Hospital Hradec Kralove

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Miroslav Solar, Principal Investigator, Charles University, Czech Republic
• ClinicalTrials.gov Identifier: NCT02127840
• Other Study ID Numbers: PAAVS1143
• First Posted: May 1, 2014
• Last Update Posted: May 1, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Miroslav Solar, Principal Investigator, Charles University, Czech Republic: primary aldosteronism; adrenal adenoma; arterial hypertension
• Additional relevant MeSH terms: Hyperaldosteronism; Epinephrine; Racepinephrine; Epinephryl borate

Study Results

No Results Posted as of May 1, 2014