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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
Sponsor:
Information provided by (Responsible Party):
Marcin Grabowski, Medical University of Warsaw

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.


Condition or disease
Heart Failure Ventricular Tachycardia Ventricular Dysfunction

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. Correlation of serum biomarkers concentrations with cardiac remodeling. [ Time Frame: up to 12 months ]
  2. Correlation of serum biomarkers concentrations with hemodynamic stress. [ Time Frame: up to 12 months ]
  3. Assessment of iron deficiency and its prognostic significance. [ Time Frame: up to 12 months ]
  4. Assessment of changes in biomarker levels in serial measurements. [ Time Frame: up to 12 months ]
  5. Correlation of serum biomarkers concentrations in patients with and without device (ICD or CRT-D) already implanted. [ Time Frame: up to 12 months ]
  6. Correlation of serum biomarkers concentrations with a size of an infarct scar. [ Time Frame: during index hospitalization ]

Biospecimen Retention:   Samples Without DNA
From each patient will be collected 10 ml of venous blood which will be centrifurgated to obtain serum.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

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


Contacts
Contact: Krzysztof Ozierański, MD 509 996 947 ext 0048 krzysztof.ozieranski@gmail.com
Contact: Paweł Balsam, PhD 605 152 120 ext 0048 pawel.balsam@me.com

Locations
Poland
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    krzysztof.ozieranski@gmail.com   
Contact: Paweł Balsam, PhD    605 152 120 ext 0048    pawel.balsam@me.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         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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

Responsible Party: Marcin Grabowski, Clinical Professor, Marcin Grabowski, Medical University of Warsaw, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02784912     History of Changes
Other Study ID Numbers: STORM
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will be able to share data for meta-analyses

Keywords provided by Marcin Grabowski, Medical University of Warsaw:
Biomarkers
Ventricular Dysfunction
Ventricular Tachycardia
Electrical Storm
ST2
Galectin-3
NT-proBNP
Iron Deficiency
hs-CRP
hs-TnT

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Ventricular Dysfunction
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes