Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation (STORM)
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|ClinicalTrials.gov Identifier: NCT02784912|
Recruitment Status : Not yet recruiting
First Posted : May 27, 2016
Last Update Posted : June 8, 2017
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.
|Condition or disease|
|Heart Failure Ventricular Tachycardia Ventricular Dysfunction|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Biomarkers-related riSk sTratification of Arrhythmia Recurrence in Patients undergOing Ablation of Sustained ventRicular Tachycardia or Electrical storM - STORM Study|
|Estimated Study Start Date :||September 2017|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||June 2018|
- Biomarker-related risk stratification of composite endpoint (cardiovascular death or rehospitalization, arrhythmia recurrence) occurrence after ablation of sustained ventricular tachycardia or electrical storm. [ Time Frame: up to 12 months ]
- 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. [ Time Frame: up to 12 months ]
- Correlation of serum biomarkers concentrations with cardiac remodeling. [ Time Frame: up to 12 months ]
- Correlation of serum biomarkers concentrations with hemodynamic stress. [ Time Frame: up to 12 months ]
- Assessment of iron deficiency and its prognostic significance. [ Time Frame: up to 12 months ]
- Assessment of changes in biomarker levels in serial measurements. [ Time Frame: up to 12 months ]
- Correlation of serum biomarkers concentrations in patients with and without device (ICD or CRT-D) already implanted. [ Time Frame: up to 12 months ]
- Correlation of serum biomarkers concentrations with a size of an infarct scar. [ Time Frame: during index hospitalization ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784912
|Contact: Krzysztof Ozierański, MD||509 996 947 ext firstname.lastname@example.org|
|Contact: Paweł Balsam, PhD||605 152 120 ext email@example.com|
|1st Department of Cariology of Medcial University of Warsaw||Not yet recruiting|
|Warsaw, Mazowieckie, Poland, 02-097|
|Contact: Krzysztof Ozierański, MD 509 996 947 ext 0048 firstname.lastname@example.org|
|Contact: Paweł Balsam, PhD 605 152 120 ext 0048 email@example.com|
|Principal Investigator: Krzysztof Ozierański, MD|
|Sub-Investigator: Paweł Balsam, PhD|
|Sub-Investigator: Marcin Grabowski, PhD|
|Sub-Investigator: Piotr Lodziński, PhD|
|Sub-Investigator: Michał Peller, MD|
|Sub-Investigator: Agata Tymińska, MD|
|Sub-Investigator: Grzegorz Opolski, Professor|
|Study Chair:||Marcin D Grabowski, PhD||1st Department of Cardiology Medical University of Warsaw|
|Study Chair:||Piotr Lodzinski, PhD||1st Department of Cardiology Medical University of Warsaw|
|Study Chair:||Grzegorz Opolski, Professor||1st Department of Cardiology Medical University of Warsaw|