NCT05794464

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
May 2023Aug 2026

First Submitted

Initial submission to the registry

March 20, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

March 20, 2023

Last Update Submit

September 6, 2023

Conditions

Atrial Fibrillation, Paroxysmal or Persistent

Keywords

atrial fibrillationsecretoneurincatheter ablationelectrical cardio version

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation recurrence based on secretoneurin levels

    Atrial fibrillation recurrence based on secretoneurin levels will be assessed

    24 months

Secondary Outcomes (1)

  • Brain injury detection

    24 months

Study Arms (1)

Catheter ablation and/or electrical cardioversion

EXPERIMENTAL

Study subjects indicated for catheter ablation and/or electrical cardioversion will be enrolled in this study arm.

Procedure: Catheter ablation and/or electrical cardioversion

Interventions

Catheter ablation and/or electrical cardioversionPROCEDURE

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

Catheter ablation and/or electrical cardioversion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (8)

  • 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.

    PMID: 25634833BACKGROUND

  • 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.

    PMID: 25634832BACKGROUND

  • 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.

    PMID: 35797660BACKGROUND

  • 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.

    PMID: 35220390BACKGROUND

  • 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.

    PMID: 27599578BACKGROUND

  • 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.

    PMID: 30185093BACKGROUND

  • 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.

    PMID: 34999932BACKGROUND

  • 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.

    PMID: 41179559DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jiří Plášek, MD,PhD,FESC

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737jiri.hyncica@fno.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking will be used in the study.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: The study subjects will be enrolled in one group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 3, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Locations

CZ(1)