Clinical trial NCT02784912: Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation
Official title: Biomarkers-related riSk sTratification of Arrhythmia Recurrence in Patients undergOing Ablation of Sustained ventRicular Tachycardia or Electrical storM - STORM Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Ventricular Tachycardia
Ventricular Dysfunction
Keywords: Biomarkers
Ventricular Dysfunction
Ventricular Tachycardia
Electrical Storm
ST2
Galectin-3
NT-proBNP
Iron Deficiency
hs-CRP
hs-TnT
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study will include patients with ischemic heart disease with reduced left ventricle ejection fraction admitted to hospital and qualified for ablation due to electrical storm or sustained ventricular tachycardia.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria (all required):

* \>= 18 years
* signed consent
* ischemic heart disease
* left ventricle ejection fraction \<= 35%
* admission to hospital due to electrical storm or sustained ventricular tachycardia and qualification for ablation of the arrhythmia
* patients with already implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy defibrillator (CRT-D) or patients qualified for implantation

Exclusion Criteria:

* non-ischemic heart disease
* current ischemia and potentially reversible causes (e.g. electrolyte abnormalities, drug intoxication) of the arrhythmia
* congenital genetic heart disease
* serious comorbidities (e.g. neoplasm)
* chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatoid arthritis)
* renal failure (creatinine \>2,5 mg/dl)

Primary outcomes:
measure: Biomarker-related risk stratification of composite endpoint (cardiovascular death or rehospitalization, arrhythmia recurrence) occurrence after ablation of sustained ventricular tachycardia or electrical storm.
timeFrame: up to 12 months
Secondary outcomes:
measure: Biomarker-related risk stratification of secondary endpoint (all-cause death or rehospitalization, intensification of atrial arrhythmia) occurrence after ablation of sustained ventricular tachycardia or electrical storm.
timeFrame: up to 12 months
Other outcomes:
measure: Correlation of serum biomarkers concentrations with cardiac remodeling.
timeFrame: up to 12 months
measure: Correlation of serum biomarkers concentrations with hemodynamic stress.
timeFrame: up to 12 months
measure: Assessment of iron deficiency and its prognostic significance.
timeFrame: up to 12 months
measure: Assessment of changes in biomarker levels in serial measurements.
timeFrame: up to 12 months
measure: Correlation of serum biomarkers concentrations in patients with and without device (ICD or CRT-D) already implanted.
timeFrame: up to 12 months
measure: Correlation of serum biomarkers concentrations with a size of an infarct scar.
timeFrame: during index hospitalization
Locations:
city: Warsaw
country: Poland
facility: 1st Department of Cariology of Medcial University of Warsaw
state: Mazowieckie
Study officials:
affiliation: 1st Department of Cardiology Medical University of Warsaw
name: Marcin D Grabowski, PhD
role: STUDY_CHAIR
affiliation: 1st Department of Cardiology Medical University of Warsaw
name: Piotr Lodzinski, PhD
role: STUDY_CHAIR
affiliation: 1st Department of Cardiology Medical University of Warsaw
name: Grzegorz Opolski, Professor
role: STUDY_CHAIR
References: