Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation

NCT02784912 | Unknown

• 1 other identifier: STORM
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Biomarker-related risk stratification of composite endpoint (cardiovascular death or rehospitalization, arrhythmia recurrence) occurrence after ablation of sustained ventricular tachycardia or electrical storm.

  up to 12 months

Secondary Outcomes (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.

  up to 12 months

Other Outcomes (6)

• Correlation of serum biomarkers concentrations with cardiac remodeling.

  up to 12 months

• Correlation of serum biomarkers concentrations with hemodynamic stress.

  up to 12 months

• Assessment of iron deficiency and its prognostic significance.

  up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \>= 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

1st Department of Cariology of Medcial University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

From each patient will be collected 10 ml of venous blood which will be centrifurgated to obtain serum.

MeSH Terms

Conditions

Heart Failure; Tachycardia, Ventricular; Ventricular Dysfunction; Iron Deficiencies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Krzysztof Ozierański, MD

CONTACT

509 996 947; krzysztof.ozieranski@gmail.com

Paweł Balsam, PhD

CONTACT

605 152 120; pawel.balsam@me.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Marcin Grabowski, Medical University of Warsaw

Study Record Dates

• First Submitted: May 21, 2016
• First Posted: May 27, 2016
• Study Start: September 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)