Primary AldosteronismPhase 4ISIRANCT02127840
Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
A Phase 4 study testing Synacthen infusion during adrenal venous sampling in people with Primary Aldosteronism, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Synacthen infusion during adrenal venous sampling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2011to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exclusion Criteria: Inability to undergo unilateral adrenalectomy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, 50005
Miroslav Solar, MD, +420495834739, miroslav.solar@fnhk.cz
About this study
The project is aimed to determine the value of synacthen infusion on the results of adrenal venous sampling in patients examined for primary aldosteronism
Read the detailed description
We aim to compare the results of adrenal venous sampling performed without and during synacthen infusion.
- Conditions
- Primary Aldosteronism
- Being tested
- Synacthen infusion during adrenal venous sampling
- Keywords
- primary aldosteronism, adrenal adenoma, arterial hypertension
- Medical subject headings
- Hyperaldosteronism, ACTH Syndrome, Ectopic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synacthen infusion during adrenal venous samplingDrug
Adrenal venous sampling during Synacthen infusion
| Study group | Role | What they receive |
|---|---|---|
| Synacthen | Experimental | Synacthen infusion during adrenal venous sampling Receives: Drug: Synacthen infusion during adrenal venous sampling |
| Without Synacthen | No intervention | Adrenal venous sampling without Synacthen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify whether Synacthen infusion may influence the results of adrenal venous sampling in patients with primary aldosteronism
Measured: End of clinical examination procedure, i.e. within 4 week after adrenal venous sampling is performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMar 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Hradec Kralove
- Responsible party
- Principal investigator, Miroslav Solar, Charles University, Czech Republic
- Investigators
- Jiri Ceral, MD, Study chair, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127840
- Sponsor's protocol ID
- PAAVS1143
- Acronym
- ISIRA
- Status last verified
- Apr 2014
- First submitted
- 25 Apr 2014
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Synacthen Infusion on the Results of Adrenal Venous Sampling in Patient With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT02127840
- Acronym / sponsor ID
- ISIRA / PAAVS1143
- Conditions
- Primary Aldosteronism
- Keywords
- primary aldosteronism, adrenal adenoma, arterial hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital Hradec Kralove
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synacthen | Experimental | Drug: Synacthen infusion during adrenal venous samplingSynacthen infusion during adrenal venous sampling |
| Without Synacthen | No intervention | –Adrenal venous sampling without Synacthen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Exclusion Criteria: Inability to undergo unilateral adrenalectomy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synacthen infusion during adrenal venous samplingAdrenal venous sampling during Synacthen infusion | Drug | Synacthen |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiri Ceral, MD study chair
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Synacthen infusion during adrenal venous sampling in people with Primary Aldosteronism, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miroslav Solar, MD (+420495834739, miroslav.solar@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.