Global Electrical Heterogeneity and Clinical Outcomes

Heart Failure Clinical Trial

— GEHCO  

Official title:

Global Electrical Heterogeneity and Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210883
• Other study ID #: STUDY00016754
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: July 5, 2021

Study information

• Verified date: July 2021
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This retrospective multicenter cohort will validate an independent association of electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD, and will validate and re-calibrate GEH ECG risk score for prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3471
• Est. completion date: July 5, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications

Exclusion Criteria:

• absent baseline pre-implant digital ECG;
• missing data on clinical predictors and covariates;
• missing ICD programming data (including number of intervals to detect [NID] or time to detect, number of detection zones, heart rate for each detection zone, and anti-tachycardia pacing [ATP] programming);
• missing outcomes data.
• records of patients with inherited channelopathies (e.g. long QT syndrome, Brugada syndrome), inherited cardiomyopathies (e.g. hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), and congenital heart disease.

Related Conditions & MeSH terms

• Heart Failure
• Implantable Defibrillator User
• Ventricular Arrythmia

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Oregon Health and Science University	Portland	Oregon
United States	Veteran Administration Portland Healthcare System	Portland	Oregon
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Larisa Tereshchenko	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (3)

Haq KT, Javadekar N, Tereshchenko LG. Detection and removal of pacing artifacts prior to automated analysis of 12-lead ECG. Comput Biol Med. 2021 Jun;133:104396. doi: 10.1016/j.compbiomed.2021.104396. Epub 2021 Apr 19. — View Citation

Waks JW, Hamilton C, Das S, Ehdaie A, Minnier J, Narayan S, Niebauer M, Raitt M, Tompkins C, Varma N, Chugh S, Tereshchenko LG. Improving sudden cardiac death risk stratification by evaluating electrocardiographic measures of global electrical heterogeneity and clinical outcomes among patients with implantable cardioverter-defibrillators: rationale and design for a retrospective, multicenter, cohort study. J Interv Card Electrophysiol. 2018 Jun;52(1):77-89. doi: 10.1007/s10840-018-0342-2. Epub 2018 Mar 14. — View Citation

Waks JW, Haq KT, Tompkins C, Rogers AJ, Ehdaie A, Bender A, Minnier J, Dalouk K, Howell S, Peiris A, Raitt M, Narayan SM, Chugh SS, Tereshchenko LG. Competing risks in patients with primary prevention implantable cardioverter-defibrillators: Global Electr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock)	Sustained ventricular tachyarrhythmia event with appropriate ICD therapy (either antitachycardia pacing or shock)	up to 15 years
Primary	Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy	All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy	up to 15 years
Secondary	sustained monomorphic ventricular tachycardia	Sustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock)	up to 15 years
Secondary	sustained polymorphic ventricular tachycardia / ventricular fibrillation	sustained polymorphic ventricular tachycardia or ventricular fibrillation with appropriate ICD therapies (either antitachycardia pacing or ICD shock)	up to 15 years