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The SAFE Prospective Registry

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05794464
Enrollment
60
Registered
2023-04-03
Start date
2023-05-01
Completion date
2026-08-31
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Paroxysmal or Persistent

Keywords

atrial fibrillation, secretoneurin, catheter ablation, electrical cardio version

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.

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.

Interventions

PROCEDURECatheter ablation and/or electrical cardioversion

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

Sponsors

University Hospital Ostrava
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

No masking will be used in the study.

Intervention model description

The study subjects will be enrolled in one group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Atrial fibrillation recurrence based on secretoneurin levels24 monthsAtrial fibrillation recurrence based on secretoneurin levels will be assessed

Secondary

MeasureTime frameDescription
Brain injury detection24 monthsBrain injury will be detected using serum protein S100B and neuron specific enolase.

Countries

Czechia

Contacts

Primary ContactJiří Hynčica
jiri.hyncica@fno.cz0042059737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026