AzTrials
AzTrials

Atrial Fibrillation, Paroxysmal or PersistentNCT05794464

The SAFE Prospective Registry

A study testing Catheter ablation and/or electrical cardioversion in people with Atrial Fibrillation, Paroxysmal or Persistent, run by University Hospital Ostrava at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Secretoneurin (SN) is a neuropeptide from the chromogranin family that influences intracellular calcium handling. SN suppresses calcium leakage from the sarcoplasmic reticulum through the ryanodine receptor. SN is a novel biomarker that has shown the potential to predict adverse arrhythmic events. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Catheter ablation and/or electrical cardioversion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCzechia
Study dates
1 May 2023to Aug 2026
Phase
Interventional
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

  • Atrial fibrillation (Afib); (paroxysmal, persistent)
  • Patients indicated for catheter ablation and/or electrical cardioversion
  • Signed informed consent

Who cannot join

  • Longstanding or permanent atrial fibrillation
  • Severe mitral regurgitation
  • Heart failure with a permanently reduced ejection fraction
  • Cerebral ischaemic stroke in < 3 months
  • Severe kidney injury
  • Severe renal insufficiency
  • Hepatic insufficiency limiting biomarker sampling
  • Myocardial infarction < 3 months

Trial locations and contacts

1 site in 1 country.

Jiří Hynčica contact

0042059737 ext. 2587

jiri.hyncica@fno.cz

Czechia1 site, 1 recruiting

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 70852

    Jiří Hynčica, 0042059737 ext. 2587, eticka.komise@fno.cz

    Jiří Plášek, MD,PhD,FESC

    Recruiting

Other trials in Czechia

About this study

Official title: Secretoneurin as a Biomarker of Atrial Fibrillation rEcurrence After Catheter Ablation/Electrical Cardioversion

Secretoneurin (SN) is a neuropeptide from the chromogranin family that influences intracellular calcium handling. SN suppresses calcium leakage from the sarcoplasmic reticulum through the ryanodine receptor. SN is a novel biomarker that has shown the potential to predict adverse arrhythmic events.

Read the detailed description

The aim of the study is to sample SN before and after catheter ablation (CA) for atrial fibrillation (Afib) to predict the recurrence after CA. Also, the uric acid/albumin ratio will be assessed as a marker of Afib recurrence. Since the uric acid/albumin ratio has been shown to be predictive of Afib in patients with myocardial infarction moreover incidence of atrial fibrillation is higher in patients with gout. As a side branch marker for silent brain injury, neuron-specific enolase (NSE) and protein S100B will be evaluated. NSE showed in small trials a significant increase after catheter ablation, as well as S100B. The prognostic power is not clear yet. From the systematic review, the most powerful predictors seem to be N-terminal (NT)-prohormone B-type natriuretic peptide (NT-Pro-BNP/BNP), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and Carboxy-terminal telopeptide of collagen type I. Biomarkers are divided into 3 main types: congestion, inflammation, and renal function.

Patients will be enrolled before catheter ablation/electrical cardioversion for Afib after signing IS, and the blood sampling will be performed the day before and the day after catheter ablation. In the electric cardioversion arm, the blood sampling will be performed before electrical cardioversion and 2h after the cardioversion before discharge.

Patients will be followed for recurrency - all patients will have a 24-hour ECG Holter and External loop recorder (MDT) for two weeks after the three months of the blanking period. Clinical outpatient control will ensue in the 4th, eighth,12, and 24 months.

Being tested
Catheter ablation and/or electrical cardioversion
Keywords
atrial fibrillation, secretoneurin, catheter ablation, electrical cardio version
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catheter ablation and/or electrical cardioversionProcedure or surgery

    Catheter ablation and/or electrical cardio version are procedures intended to treat atrial fibrillation.

Study groups in NCT05794464
Study groupRoleWhat they receive
Catheter ablation and/or electrical cardioversionExperimentalStudy subjects indicated for catheter ablation and/or electrical cardioversion will be enrolled in this study arm.
Receives: Procedure: Catheter ablation and/or electrical cardioversion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Atrial fibrillation recurrence based on secretoneurin levels

    Atrial fibrillation recurrence based on secretoneurin levels will be assessed

    Measured: 24 months

Secondary outcomes (1)

  1. Brain injury detection

    Brain injury will be detected using serum protein S100B and neuron specific enolase.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start1 May 2023
  3. Primary completionMay 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

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 N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
The study subjects will be enrolled in one group.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05794464
Sponsor's protocol ID
FNO-IKK-SAFE
Status last verified
Sep 2023
First submitted
20 Mar 2023
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Publications

  • Anderson ME. Will secretoneurin be the next big thing? J Am Coll Cardiol. 2015 Feb 3;65(4):352-354. doi: 10.1016/j.jacc.2014.11.028. No abstract available.

    PubMed 25634833

  • Ottesen AH, Louch WE, Carlson CR, Landsverk OJB, Kurola J, Johansen RF, Moe MK, Aronsen JM, Hoiseth AD, Jarstadmarken H, Nygard S, Bjoras M, Sjaastad I, Pettila V, Stridsberg M, Omland T, Christensen G, Rosjo H. Secretoneurin is a novel prognostic cardiovascular biomarker associated with cardiomyocyte calcium handling. J Am Coll Cardiol. 2015 Feb 3;65(4):339-351. doi: 10.1016/j.jacc.2014.10.065.

    PubMed 25634832

  • Selcuk M, Cinar T, Saylik F, Akbulut T, Asal S, Cicek V, Hayiroglu MI, Tanboga IH. Predictive value of uric acid/albumin ratio for the prediction of new-onset atrial fibrillation in patients with ST-Elevation myocardial infarction. Rev Invest Clin. 2022 May 2;74(3):156-164. doi: 10.24875/RIC.22000072.

    PubMed 35797660

  • Zhong X, Jiao H, Zhao D, Teng J. Serum Uric Acid Levels in Relation to Atrial Fibrillation: A Case-Control Study. Med Sci Monit. 2022 Feb 27;28:e934007. doi: 10.12659/MSM.934007.

    PubMed 35220390

  • Kuo YJ, Tsai TH, Chang HP, Chua S, Chung SY, Yang CH, Lin CJ, Wu CJ, Hang CL. The risk of atrial fibrillation in patients with gout: a nationwide population-based study. Sci Rep. 2016 Sep 7;6:32220. doi: 10.1038/srep32220.

    PubMed 27599578

  • Acibuca A, Vurgun VK, Gerede DM, Altin AT, Gul IS, Candemir B, Isikay Togay C, Kilickap M, Akyurek O. Serum neuron-specific enolase, a marker of neuronal injury, increases after catheter ablation of atrial fibrillation. J Int Med Res. 2018 Nov;46(11):4518-4526. doi: 10.1177/0300060518767768. Epub 2018 Sep 5.

    PubMed 30185093

  • Boyalla V, Harling L, Snell A, Kralj-Hans I, Barradas-Pires A, Haldar S, Khan HR, Cleland JGF, Athanasiou T, Harding SE, Wong T. Biomarkers as predictors of recurrence of atrial fibrillation post ablation: an updated and expanded systematic review and meta-analysis. Clin Res Cardiol. 2022 Jun;111(6):680-691. doi: 10.1007/s00392-021-01978-w. Epub 2022 Jan 9.

    PubMed 34999932

  • Plasek J, Vrtal J, Chobolova N, Svagera Z, Drienikova D, Pudich J, Rachela M, Stejskal D, Dodulik J, Vaclavik J. Secretoneurin plasma levels are decreased after catheter ablation for atrial fibrillation-patients with AF produce lower SN levels than healthy individuals: the SAFE registry. Front Cardiovasc Med. 2025 Oct 16;12:1664855. doi: 10.3389/fcvm.2025.1664855. eCollection 2025.

    PubMed 41179559

Questions about this trial

What is this clinical trial studying?

A study testing Catheter ablation and/or electrical cardioversion in people with Atrial Fibrillation, Paroxysmal or Persistent, run by University Hospital Ostrava 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 3 inclusion and 8 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 7 Sep 2023. 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.

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 Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial fibrillation recurrence based on secretoneurin levels (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05794464, which also lists 8 linked publications.

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 7 Sep 2023.

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