Heart Failure Clinical Trial
Official title:
Biomarkers-related riSk sTratification of Arrhythmia Recurrence in Patients undergOing Ablation of Sustained ventRicular Tachycardia or Electrical storM - STORM Study
Prevalence of HF reaches 1-2% of developed populations, and consequently a significant
problem becomes more frequent occurrence of ventricular arrhythmias (VA) - sustained
ventricular tachycardia (sVT) and electrical storm (ES) requiring radiofrequency ablation.
The aim of the study is to create a model of risk stratification to identify patients with
increased risk of occurrence of composite (cardiovascular death or rehospitalization,
arrhythmia recurrence) and secondary (inadequate device therapy, all-cause death or
rehospitalization, intensification of atrial arrhythmia) endpoints after ablation of ES or
sustained VT. Model will be based on additional measurements of N-terminal pro brain
natriuretic peptide (NT-proBNP), Galectin-3, suppressor of tumorigenicity 2 (ST2), high
sensitive troponin T (hs-TnT), high sensitive C-reactive protein (hs-CRP), iron deficiency
to clinical-, electrocardiographic- and echocardiographic assessment.
Patients with ischemic heart failure (HF) and reduced left ventricle ejection fraction are
at high risk for recurrence of VA, ultimately leading to death. Such patients often require
ablation. On the other hand, ablation of the VA in patients with post-infarction scar is a
technically difficult procedure and often is associated with short-term efficacy.
Risk factors for recurrence of VA are difficult to identify, although there are mentioned
e.g. reduced left ventricular ejection fraction, exacerbation of chronic HF and electrolyte
abnormalities.
VA is triggered by ongoing inflammation and fibrosis, which are reflected by a level of
biomarkers. Thus, it is worth searching for biomarkers that increase the possibility of
effective stratification of risk of arrhythmia recurrence in patients undergoing ablation of
sVT or ES.
The hypothesis of this study is that biomarker-related risk stratification may be beneficial
for patients with ES or sVT.
Sample size assessment was made to specify the number of participants necessary to
demonstrate an effect.
The study will include at least 50 patients (who meet the inclusion/exclusion criteria) with
ischemic heart failure, with reduced left ventricle ejection fraction admitted to hospital
and qualified for ablation due to ES or sVT.
For every patient will be provided case report forms (CRFs) including their clinical status
at admission and at discharge, laboratory findings, management during index hospitalization,
data from ablation procedure, pharmacotherapy, as well as in-hospital and one-year outcome.
Serum will be collected before ablation and 1-month after discharge from hospital for
biomarkers measurements. Patients will be tele-monitored for ≥12-months. There will be
carried out two control visits (including assessment of clinical, echocardiographic,
electrocardiographic and Holter-ECG parameters) on 1- and 3 months after discharge.
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