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

Heart Failure Clinical Trial

— STORM  

Official title:

Biomarkers-related riSk sTratification of Arrhythmia Recurrence in Patients undergOing Ablation of Sustained ventRicular Tachycardia or Electrical storM - STORM Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02784912
• Other study ID #: STORM
• Status: Not yet recruiting
• Phase: N/A
• First received: May 21, 2016
• Last updated: June 7, 2017
• Start date: September 2017
• Est. completion date: June 2018

Study information

• Verified date: June 2017
• Source: Medical University of Warsaw
• Contact: Krzysztof Ozieranski, MD
• Phone: 509 996 947
• Email: krzysztof.ozieranski[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Dysfunction
• Ventricular Tachycardia

Locations

Country	Name	City	State
Poland	1st Department of Cariology of Medcial University of Warsaw	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of serum biomarkers concentrations with cardiac remodeling.		up to 12 months
Other	Correlation of serum biomarkers concentrations with hemodynamic stress.		up to 12 months
Other	Assessment of iron deficiency and its prognostic significance.		up to 12 months
Other	Assessment of changes in biomarker levels in serial measurements.		up to 12 months
Other	Correlation of serum biomarkers concentrations in patients with and without device (ICD or CRT-D) already implanted.		up to 12 months
Other	Correlation of serum biomarkers concentrations with a size of an infarct scar.		during index hospitalization
Primary	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	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