Heart FailureGEHCONCT03210883
Global Electrical Heterogeneity and Clinical Outcomes
An observational study of Heart Failure and Implantable Defibrillator User, run by Larisa Tereshchenko at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Heart Failure, Implantable Defibrillator User, Ventricular Arrythmia
- How many people
- 3,471 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Jul 2017to 5 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: retrospective records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications
Who may be able to join
- records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado
Aurora, Colorado, 80045
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Oregon Health and Science University
Portland, Oregon, 97239
Veteran Administration Portland Healthcare System
Portland, Oregon, 97239
Stanford University
Stanford, California, 94305
About this study
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.
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 15 years
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
Measured: up to 15 years
Secondary outcomes (2)
sustained monomorphic ventricular tachycardia
Sustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock)
Measured: up to 15 years
sustained polymorphic ventricular tachycardia / ventricular fibrillation
sustained polymorphic ventricular tachycardia or ventricular fibrillation with appropriate ICD therapies (either antitachycardia pacing or ICD shock)
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Jul 2017
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larisa Tereshchenko
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor-investigator, Larisa Tereshchenko, Oregon Health and Science University
- Investigators
- Larisa G Tereshchenko, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210883
- Sponsor's protocol ID
- STUDY00016754
- Acronym
- GEHCO
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2017
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29541969Waks 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 Electrical Heterogeneity and Clinical Outcomes study. Heart Rhythm. 2021 Jun;18(6):977-986. doi: 10.1016/j.hrthm.2021.03.006. Epub 2021 Mar 6.
PubMed 33684549Haq 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.
PubMed 33872969Tereshchenko LG, Waks JW, Tompkins C, Rogers AJ, Ehdaie A, Henrikson CA, Dalouk K, Raitt M, Kewalramani S, Kattan MW, Santangeli P, Wilkoff BW, Kapadia SR, Narayan SM, Chugh SS. Competing risks of monomorphic vs. non-monomorphic ventricular arrhythmias in primary prevention implantable cardioverter-defibrillator recipients: Global Electrical Heterogeneity and Clinical Outcomes (GEHCO) study. Europace. 2024 Jun 3;26(6):euae127. doi: 10.1093/europace/euae127.
PubMed 38703375
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Electrical Heterogeneity and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03210883
- Acronym / sponsor ID
- GEHCO / STUDY00016754
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,471 participants (actual)
- Lead sponsor
- Larisa TereshchenkoUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- retrospective records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications
Key inclusion criteria (1 listed)
- records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock)
Time frame: up to 15 years
Sustained ventricular tachyarrhythmia event with appropriate ICD therapy (either antitachycardia pacing or shock)
Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy
Time frame: up to 15 years
All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy
2 secondary outcomes
sustained monomorphic ventricular tachycardia
Time frame: up to 15 years
sustained polymorphic ventricular tachycardia / ventricular fibrillation
Time frame: up to 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Background: PubMed 29541969Waks 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.
- Results publication: PubMed 33684549Waks 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 Electrical Heterogeneity and Clinical Outcomes study. Heart Rhythm. 2021 Jun;18(6):977-986. doi: 10.1016/j.hrthm.2021.03.006. Epub 2021 Mar 6.
- Results publication: PubMed 33872969Haq 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.
- Derived from this study: PubMed 38703375Tereshchenko LG, Waks JW, Tompkins C, Rogers AJ, Ehdaie A, Henrikson CA, Dalouk K, Raitt M, Kewalramani S, Kattan MW, Santangeli P, Wilkoff BW, Kapadia SR, Narayan SM, Chugh SS. Competing risks of monomorphic vs. non-monomorphic ventricular arrhythmias in primary prevention implantable cardioverter-defibrillator recipients: Global Electrical Heterogeneity and Clinical Outcomes (GEHCO) study. Europace. 2024 Jun 3;26(6):euae127. doi: 10.1093/europace/euae127.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larisa G Tereshchenko, MD, PhD principal investigator
Oregon Health and Science University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Implantable Defibrillator User, run by Larisa Tereshchenko at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock) (time frame: up to 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210883, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.