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Recruiting

NCT Number: NCT05794464

The SAFE Prospective Registry

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location status: Recruiting

Location contact

David Stejskal, prof.,MD,PhD,EurChem

SUB_INVESTIGATOR

Jan Václavík, prof.,MD,PhD,FESC

SUB_INVESTIGATOR

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Jiří Plášek, MD,PhD,FESC

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Catheter ablation and/or electrical cardioversion

Procedure

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

Primary outcomes

  1. Atrial fibrillation recurrence based on secretoneurin levels

    Time frame: 24 months

    Atrial fibrillation recurrence based on secretoneurin levels will be assessed

Secondary outcomes

  1. Brain injury detection

    Time frame: 24 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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