Congestive Heart FailureICD-EGMsNCT00916435
Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac Electrograms
An observational study of Congestive Heart Failure and Sudden Cardiac Death, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used: to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and to predict progression of heart failure in patients with ICD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Sudden Cardiac Death, Arrhythmia
- How many people
- 630 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to Dec 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary or secondary prevention of sudden cardiac death
Who may be able to join
- history of acute MI at least 4 weeks old
- non-ischemic LV dysfunction for at least 9 months
- who have an EF < or = to 35%
- who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia)
- undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD
Who cannot join
- inability or unwillingness to provide valid informed consent
- pregnancy
- any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure
The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used:
- to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and
- to predict progression of heart failure in patients with ICD.
- Keywords
- Arrhythmia, Cardiac Arrest, Cardiomyopathy, Heart Failure
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac, Arrhythmias, Cardiac, Cardiomyopathies, Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)
Measured: from enrollment up to 72 months
Secondary outcomes (2)
Composite heart failure outcome (HF hospitalization, HF death, heart transplant)
Measured: from enrollment up to 72 months
All-cause mortality
Measured: from enrollment up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startMar 2005
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Larisa Tereshchenko, Johns Hopkins University
- Investigators
- Larisa G Tereshchenko, MD, PhD, Principal investigator, Johns Hopkins UniversityRonald D Berger, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916435
- Sponsor's protocol ID
- 1K99HL094665-01 (in review)
- Acronym
- ICD-EGMs
- Status last verified
- Apr 2015
- First submitted
- 8 Jun 2009
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tereshchenko LG, Fetics BJ, Domitrovich PP, Lindsay BD, Berger RD. Prediction of ventricular tachyarrhythmias by intracardiac repolarization variability analysis. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):276-84. doi: 10.1161/CIRCEP.108.829440. Epub 2009 Mar 6.
PubMed 19808478Tereshchenko LG, Fetics BJ, Berger RD. Intracardiac QT variability in patients with structural heart disease on class III antiarrhythmic drugs. J Electrocardiol. 2009 Nov-Dec;42(6):505-10. doi: 10.1016/j.jelectrocard.2009.07.011. Epub 2009 Aug 22.
PubMed 19700170Tereshchenko LG, Faddis MN, Fetics BJ, Zelik KE, Efimov IR, Berger RD. Transient local injury current in right ventricular electrogram after implantable cardioverter-defibrillator shock predicts heart failure progression. J Am Coll Cardiol. 2009 Aug 25;54(9):822-8. doi: 10.1016/j.jacc.2009.06.004.
PubMed 19695461Stempniewicz P, Cheng A, Connolly A, Wang XY, Calkins H, Tomaselli GF, Berger RD, Tereshchenko LG. Appropriate and inappropriate electrical therapies delivered by an implantable cardioverter-defibrillator: effect on intracardiac electrogram. J Cardiovasc Electrophysiol. 2011 May;22(5):554-60. doi: 10.1111/j.1540-8167.2010.01958.x. Epub 2010 Nov 18.
PubMed 21087331Oosterhoff P, Tereshchenko LG, van der Heyden MA, Ghanem RN, Fetics BJ, Berger RD, Vos MA. Short-term variability of repolarization predicts ventricular tachycardia and sudden cardiac death in patients with structural heart disease: a comparison with QT variability index. Heart Rhythm. 2011 Oct;8(10):1584-90. doi: 10.1016/j.hrthm.2011.04.033. Epub 2011 May 10.
PubMed 21699842Tereshchenko LG, Henrikson CA, Stempniewicz P, Han L, Berger RD. Antiarrhythmic effect of reverse electrical remodeling associated with cardiac resynchronization therapy. Pacing Clin Electrophysiol. 2011 Mar;34(3):357-64. doi: 10.1111/j.1540-8159.2010.02974.x. Epub 2010 Nov 22.
PubMed 21091740Chen X, Tereshchenko LG, Berger RD, Trayanova NA. Arrhythmia risk stratification based on QT interval instability: an intracardiac electrocardiogram study. Heart Rhythm. 2013 Jun;10(6):875-80. doi: 10.1016/j.hrthm.2013.02.014. Epub 2013 Feb 13.
PubMed 23416373Das D, Han L, Berger RD, Tereshchenko LG. QT variability paradox after premature ventricular contraction in patients with structural heart disease and ventricular arrhythmias. J Electrocardiol. 2012 Nov-Dec;45(6):652-7. doi: 10.1016/j.jelectrocard.2012.07.016. Epub 2012 Sep 17.
PubMed 22995383Baumert M, Kabir MM, Dalouk K, Henrikson CA, Tereshchenko LG. VV' Alternans Triplets on Near-Field ICD Intracardiac Electrogram is Associated with Mortality. Pacing Clin Electrophysiol. 2015 May;38(5):547-57. doi: 10.1111/pace.12594. Epub 2015 Mar 9.
PubMed 25752990Guduru A, Lansdown J, Chernichenko D, Berger RD, Tereshchenko LG. Longitudinal changes in intracardiac repolarization lability in patients with implantable cardioverter-defibrillator. Front Physiol. 2013 Aug 12;4:208. doi: 10.3389/fphys.2013.00208. eCollection 2013.
PubMed 23964242Tereshchenko LG, McCabe A, Han L, Sur S, Huang T, Marine JE, Cheng A, Spragg DD, Sinha S, Calkins H, Stein K, Tomaselli GF, Berger RD. Intracardiac J-point elevation before the onset of polymorphic ventricular tachycardia and ventricular fibrillation in patients with an implantable cardioverter-defibrillator. Heart Rhythm. 2012 Oct;9(10):1594-602. doi: 10.1016/j.hrthm.2012.06.036. Epub 2012 Jun 29.
PubMed 22750217
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of the ICD Intracardiac Electrograms for Prediction of Ventricular Tachyarrhythmias and Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00916435
- Acronym / sponsor ID
- ICD-EGMs / 1K99HL094665-01 (in review)
- Keywords
- Arrhythmia, Cardiac Arrest, Cardiomyopathy, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Mar 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Jun 2009 (estimated)
- 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.
The purpose of this study is to determine whether waveforms of the intracardiac electrograms, acquired through an ICD, can be used:
- to predict malignant ventricular arrhythmias, requiring appropriate ICD therapies, and
- to predict progression of heart failure in patients with ICD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary or secondary prevention of sudden cardiac death
Key inclusion criteria (5 listed)
- history of acute MI at least 4 weeks old
- non-ischemic LV dysfunction for at least 9 months
- who have an EF < or = to 35%
- who was resuscitated from sudden cardiac arrest (ventricular tachyarrhythmia)
- undergone implantation of an FDA-approved ICD for primary or secondary prevention of SCD
Key exclusion criteria (3 listed)
- inability or unwillingness to provide valid informed consent
- pregnancy
- any condition other than cardiac disease that was associated with a high likelihood of death during 1 year after enrollment
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
sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP)
Time frame: from enrollment up to 72 months
2 secondary outcomes
Composite heart failure outcome (HF hospitalization, HF death, heart transplant)
Time frame: from enrollment up to 72 months
All-cause mortality
Time frame: from enrollment up to 72 months
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 21 Apr 2015.
- Results publication: PubMed 19808478Tereshchenko LG, Fetics BJ, Domitrovich PP, Lindsay BD, Berger RD. Prediction of ventricular tachyarrhythmias by intracardiac repolarization variability analysis. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):276-84. doi: 10.1161/CIRCEP.108.829440. Epub 2009 Mar 6.
- Results publication: PubMed 19700170Tereshchenko LG, Fetics BJ, Berger RD. Intracardiac QT variability in patients with structural heart disease on class III antiarrhythmic drugs. J Electrocardiol. 2009 Nov-Dec;42(6):505-10. doi: 10.1016/j.jelectrocard.2009.07.011. Epub 2009 Aug 22.
- Results publication: PubMed 19695461Tereshchenko LG, Faddis MN, Fetics BJ, Zelik KE, Efimov IR, Berger RD. Transient local injury current in right ventricular electrogram after implantable cardioverter-defibrillator shock predicts heart failure progression. J Am Coll Cardiol. 2009 Aug 25;54(9):822-8. doi: 10.1016/j.jacc.2009.06.004.
- Results publication: PubMed 21087331Stempniewicz P, Cheng A, Connolly A, Wang XY, Calkins H, Tomaselli GF, Berger RD, Tereshchenko LG. Appropriate and inappropriate electrical therapies delivered by an implantable cardioverter-defibrillator: effect on intracardiac electrogram. J Cardiovasc Electrophysiol. 2011 May;22(5):554-60. doi: 10.1111/j.1540-8167.2010.01958.x. Epub 2010 Nov 18.
- Results publication: PubMed 21699842Oosterhoff P, Tereshchenko LG, van der Heyden MA, Ghanem RN, Fetics BJ, Berger RD, Vos MA. Short-term variability of repolarization predicts ventricular tachycardia and sudden cardiac death in patients with structural heart disease: a comparison with QT variability index. Heart Rhythm. 2011 Oct;8(10):1584-90. doi: 10.1016/j.hrthm.2011.04.033. Epub 2011 May 10.
- Results publication: PubMed 21091740Tereshchenko LG, Henrikson CA, Stempniewicz P, Han L, Berger RD. Antiarrhythmic effect of reverse electrical remodeling associated with cardiac resynchronization therapy. Pacing Clin Electrophysiol. 2011 Mar;34(3):357-64. doi: 10.1111/j.1540-8159.2010.02974.x. Epub 2010 Nov 22.
- Results publication: PubMed 23416373Chen X, Tereshchenko LG, Berger RD, Trayanova NA. Arrhythmia risk stratification based on QT interval instability: an intracardiac electrocardiogram study. Heart Rhythm. 2013 Jun;10(6):875-80. doi: 10.1016/j.hrthm.2013.02.014. Epub 2013 Feb 13.
- Results publication: PubMed 22995383Das D, Han L, Berger RD, Tereshchenko LG. QT variability paradox after premature ventricular contraction in patients with structural heart disease and ventricular arrhythmias. J Electrocardiol. 2012 Nov-Dec;45(6):652-7. doi: 10.1016/j.jelectrocard.2012.07.016. Epub 2012 Sep 17.
- Results publication: PubMed 25752990Baumert M, Kabir MM, Dalouk K, Henrikson CA, Tereshchenko LG. VV' Alternans Triplets on Near-Field ICD Intracardiac Electrogram is Associated with Mortality. Pacing Clin Electrophysiol. 2015 May;38(5):547-57. doi: 10.1111/pace.12594. Epub 2015 Mar 9.
- Results publication: PubMed 23964242Guduru A, Lansdown J, Chernichenko D, Berger RD, Tereshchenko LG. Longitudinal changes in intracardiac repolarization lability in patients with implantable cardioverter-defibrillator. Front Physiol. 2013 Aug 12;4:208. doi: 10.3389/fphys.2013.00208. eCollection 2013.
- Results publication: PubMed 22750217Tereshchenko LG, McCabe A, Han L, Sur S, Huang T, Marine JE, Cheng A, Spragg DD, Sinha S, Calkins H, Stein K, Tomaselli GF, Berger RD. Intracardiac J-point elevation before the onset of polymorphic ventricular tachycardia and ventricular fibrillation in patients with an implantable cardioverter-defibrillator. Heart Rhythm. 2012 Oct;9(10):1594-602. doi: 10.1016/j.hrthm.2012.06.036. Epub 2012 Jun 29.
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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
Johns Hopkins University
Ronald D Berger, MD, PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Sudden Cardiac Death, run by Johns Hopkins University at 2 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 5 inclusion and 3 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
sustained ventricular tachycardia with appropriate ICD therapies (either shock or ATP) (time frame: from enrollment up to 72 months). 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 NCT00916435, which also lists 11 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 21 Apr 2015.