Ischemic CardiomyopathyNCT01076660
Left Ventricular Structural Predictors of Sudden Cardiac Death
An observational study of Ischemic Cardiomyopathy and Nonischemic Cardiomyopathy, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with poor heart function. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2003to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with LV ejection fraction (LVEF) ≤35% of ischemic or nonischemic etiology (as measured by a clinical echocardiogram, ventriculogram, or radionuclide study) referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
Who may be able to join
- LVEF≤35%, referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
- Between the ages of 21 and 80 years old
- Permission of the patient's clinical attending physician
Who cannot join
- Patients who refuse or are unable to give consent.
- Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles)
- Minors.
- Pregnant women.
- NYHA Class IV heart failure.
- Chronic renal insufficiency with creatinine clearance<60 ml/min; acute renal insufficiency of any severity
- Claustrophobia
- Prior adverse reaction to gadolinium-based contrast
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
Katherine Wu, MD
- Active, not recruiting
Christiana Care Health Services
Newark, Delaware, 19718
About this study
Official title: Left Ventricular Structural Predictors of Sudden Cardiac Death [Substudy of: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death, See Also NCT000181233]
Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with poor heart function. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of reduced heart function, specifically left ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification.
This project examines the hypothesis that structural abnormalities of the heart itself, above and beyond global LV dysfunction, are important predictors of SCD risk since they indicate the presence of the abnormal tissue substrate required for the abnormal electrical circuits and heart rhythms that actually lead to SCD. Information about the heart's structure will be obtained from cardiac magnetic resonance imaging and used in combination with a number of other clinical risk factors to see if certain characteristics can better predict patients at risk for SCD.
Read the detailed description
Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with left ventricular (LV) systolic dysfunction. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of LV ejection fraction (LVEF)≤35% as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification.
This project examines the hypothesis that LV structural abnormalities above and beyond global LV dysfunction are important predictors of SCD risk since they indicate the presence of abnormal pathophysiologic substrate required for the ventricular arrhythmogenicity leading to SCD. This premise is supported by pre-clinical models and limited patient cohort studies examining the contribution of individual LV structural indices. However, there has been no prospective study of primary prevention ICD candidates in sufficiently large numbers to investigate the incremental value of a comprehensive assessment of LV structure on SCD risk over and above that of LVEF and readily available demographic and clinical variables.
LV structure can be quantified in detail using cardiac magnetic resonance imaging with late gadolinium enhancement (CMR-LGE). Specifically, accurate assessment of global LV function, volumes, mass, geometry, and infarct/scar characteristics are feasible and obtainable clinically in a single examination. We aim to examine whether or not any of these CMR indices or combination of indices are better able to discriminate between patients with high versus low susceptibility to SCD within the broader population of reduced LVEF patients. If the results of these studies demonstrate that LV structure is an important prognostic risk factor, it may be then be possible to more specifically focus ICD therapy to those who are most likely to benefit and avoid unnecessary device implantations.
- Keywords
- Ischemic cardiomyopathy, Nonischemic cardiomyopathy, Implantable cardioverter defibrillator, Sudden Cardiac Death, Ventricular tachycardia, Ventricular fibrillation
- Medical subject headings
- Death, Sudden, Cardiac, Tachycardia, Ventricular, Ventricular Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite SCD outcomes
The first occurrence of an adjudicated appropriate ICD firing for ventricular tachycardia/ventricular fibrillation or cardiac death not treated by the ICD.
Measured: Every 6 months for 5 years
Secondary outcomes (1)
Composite cardiac outcomes
The first occurrence of an adjudicated appropriate ICD firing for ventricular tachycardia/ventricular fibrillation, hospitalization for heart failure or cardiac death.
Measured: Every 6 months for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startOct 2003
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Ischemic CardiomyopathyStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Donald W. Reynolds Foundation, Christiana Care Health Services
- Responsible party
- Sponsor
- Investigators
- Katherine Wu, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076660
- Sponsor's protocol ID
- IRB00324567
- Status last verified
- Jan 2026
- First submitted
- 25 Feb 2010
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schmidt A, Azevedo CF, Cheng A, Gupta SN, Bluemke DA, Foo TK, Gerstenblith G, Weiss RG, Marban E, Tomaselli GF, Lima JA, Wu KC. Infarct tissue heterogeneity by magnetic resonance imaging identifies enhanced cardiac arrhythmia susceptibility in patients with left ventricular dysfunction. Circulation. 2007 Apr 17;115(15):2006-14. doi: 10.1161/CIRCULATIONAHA.106.653568. Epub 2007 Mar 26.
PubMed 17389270Fernandes VR, Wu KC, Rosen BD, Schmidt A, Lardo AC, Osman N, Halperin HR, Tomaselli G, Berger R, Bluemke DA, Marban E, Lima JA. Enhanced infarct border zone function and altered mechanical activation predict inducibility of monomorphic ventricular tachycardia in patients with ischemic cardiomyopathy. Radiology. 2007 Dec;245(3):712-9. doi: 10.1148/radiol.2452061615. Epub 2007 Oct 2.
PubMed 17911537Wu KC, Weiss RG, Thiemann DR, Kitagawa K, Schmidt A, Dalal D, Lai S, Bluemke DA, Gerstenblith G, Marban E, Tomaselli GF, Lima JA. Late gadolinium enhancement by cardiovascular magnetic resonance heralds an adverse prognosis in nonischemic cardiomyopathy. J Am Coll Cardiol. 2008 Jun 24;51(25):2414-21. doi: 10.1016/j.jacc.2008.03.018.
PubMed 18565399Ouwerkerk R, Bottomley PA, Solaiyappan M, Spooner AE, Tomaselli GF, Wu KC, Weiss RG. Tissue sodium concentration in myocardial infarction in humans: a quantitative 23Na MR imaging study. Radiology. 2008 Jul;248(1):88-96. doi: 10.1148/radiol.2481071027.
PubMed 18566171Ardekani S, Weiss RG, Lardo AC, George RT, Lima JA, Wu KC, Miller MI, Winslow RL, Younes L. Computational method for identifying and quantifying shape features of human left ventricular remodeling. Ann Biomed Eng. 2009 Jun;37(6):1043-54. doi: 10.1007/s10439-009-9677-2. Epub 2009 Mar 26.
PubMed 19322659Bottomley PA, Wu KC, Gerstenblith G, Schulman SP, Steinberg A, Weiss RG. Reduced myocardial creatine kinase flux in human myocardial infarction: an in vivo phosphorus magnetic resonance spectroscopy study. Circulation. 2009 Apr 14;119(14):1918-24. doi: 10.1161/CIRCULATIONAHA.108.823187. Epub 2009 Mar 30.
PubMed 19332463Strauss DG, Selvester RH, Lima JA, Arheden H, Miller JM, Gerstenblith G, Marban E, Weiss RG, Tomaselli GF, Wagner GS, Wu KC. ECG quantification of myocardial scar in cardiomyopathy patients with or without conduction defects: correlation with cardiac magnetic resonance and arrhythmogenesis. Circ Arrhythm Electrophysiol. 2008 Dec;1(5):327-36. doi: 10.1161/CIRCEP.108.798660. Epub 2008 Dec 2.
PubMed 19808427Strauss DG, Wu KC. Imaging myocardial scar and arrhythmic risk prediction--a role for the electrocardiogram? J Electrocardiol. 2009 Mar-Apr;42(2):138.e1-8. doi: 10.1016/j.jelectrocard.2008.12.010. Epub 2009 Jan 30.
PubMed 19185315Arevalo HJ, Vadakkumpadan F, Guallar E, Jebb A, Malamas P, Wu KC, Trayanova NA. Arrhythmia risk stratification of patients after myocardial infarction using personalized heart models. Nat Commun. 2016 May 10;7:11437. doi: 10.1038/ncomms11437.
PubMed 27164184Zhang Y, Guallar E, Weiss RG, Stillabower M, Gerstenblith G, Tomaselli GF, Wu KC. Associations between scar characteristics by cardiac magnetic resonance and changes in left ventricular ejection fraction in primary prevention defibrillator recipients. Heart Rhythm. 2016 Aug;13(8):1661-6. doi: 10.1016/j.hrthm.2016.04.013. Epub 2016 Apr 19.
PubMed 27108939Wu KC, Gerstenblith G, Guallar E, Marine JE, Dalal D, Cheng A, Marban E, Lima JA, Tomaselli GF, Weiss RG. Combined cardiac magnetic resonance imaging and C-reactive protein levels identify a cohort at low risk for defibrillator firings and death. Circ Cardiovasc Imaging. 2012 Mar;5(2):178-86. doi: 10.1161/CIRCIMAGING.111.968024. Epub 2012 Jan 20.
PubMed 22267750Sani MM, Sung E, Engels M, Daimee UA, Trayanova N, Wu KC, Chrispin J. Association of epicardial and intramyocardial fat with ventricular arrhythmias. Heart Rhythm. 2023 Dec;20(12):1699-1705. doi: 10.1016/j.hrthm.2023.08.033. Epub 2023 Aug 26.
PubMed 37640127Binder MS, Yanek LR, Yang W, Butcher B, Norgard S, Marine JE, Kolandaivelu A, Chrispin J, Fedarko NS, Calkins H, O'Rourke B, Wu KC, Tomaselli GF, Barth AS. Growth Differentiation Factor-15 Predicts Mortality and Heart Failure Exacerbation But Not Ventricular Arrhythmias in Patients With Cardiomyopathy. J Am Heart Assoc. 2023 Feb 7;12(3):e8023. doi: 10.1161/JAHA.122.026003. Epub 2023 Jan 31.
PubMed 36718879Vakil RM, Marine JE, Kolandaivelu A, Dickfeld T, Weiss RG, Tomaselli GF, Chrispin J, Wu KC. The Association of Clustered Ventricular Arrhythmia and Cycle Length With Scar Burden in Cardiomyopathy. JACC Clin Electrophysiol. 2022 Aug;8(8):957-966. doi: 10.1016/j.jacep.2022.05.008. Epub 2022 Jul 27.
PubMed 35981800Daimee UA, Sung E, Engels M, Halushka MK, Berger RD, Trayanova NA, Wu KC, Chrispin J. Association of left ventricular tissue heterogeneity and intramyocardial fat on computed tomography with ventricular arrhythmias in ischemic cardiomyopathy. Heart Rhythm O2. 2022 Apr 2;3(3):241-247. doi: 10.1016/j.hroo.2022.03.005. eCollection 2022 Jun.
PubMed 35734302
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Structural Predictors of Sudden Cardiac Death [Substudy of: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death, See Also NCT000181233]
- ClinicalTrials.gov ID
- NCT01076660
- Acronym / sponsor ID
- IRB00324567
- Keywords
- Ischemic cardiomyopathy, Nonischemic cardiomyopathy, Implantable cardioverter defibrillator, Sudden Cardiac Death, Ventricular tachycardia, Ventricular fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Donald W. Reynolds Foundation, Christiana Care Health Services
- Study start
- Oct 2003
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 26 Feb 2010 (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.
Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with poor heart function. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of reduced heart function, specifically left ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification.
This project examines the hypothesis that structural abnormalities of the heart itself, above and beyond global LV dysfunction, are important predictors of SCD risk since they indicate the presence of the abnormal tissue substrate required for the abnormal electrical circuits and heart rhythms that actually lead to SCD. Information about the heart's structure will be obtained from cardiac magnetic resonance imaging and used in combination with a number of other clinical risk factors to see if certain characteristics can better predict patients at risk for SCD.
Detailed description
Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with left ventricular (LV) systolic dysfunction. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of LV ejection fraction (LVEF)≤35% as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification.
This project examines the hypothesis that LV structural abnormalities above and beyond global LV dysfunction are important predictors of SCD risk since they indicate the presence of abnormal pathophysiologic substrate required for the ventricular arrhythmogenicity leading to SCD. This premise is supported by pre-clinical models and limited patient cohort studies examining the contribution of individual LV structural indices. However, there has been no prospective study of primary prevention ICD candidates in sufficiently large numbers to investigate the incremental value of a comprehensive assessment of LV structure on SCD risk over and above that of LVEF and readily available demographic and clinical variables.
LV structure can be quantified in detail using cardiac magnetic resonance imaging with late gadolinium enhancement (CMR-LGE). Specifically, accurate assessment of global LV function, volumes, mass, geometry, and infarct/scar characteristics are feasible and obtainable clinically in a single examination. We aim to examine whether or not any of these CMR indices or combination of indices are better able to discriminate between patients with high versus low susceptibility to SCD within the broader population of reduced LVEF patients. If the results of these studies demonstrate that LV structure is an important prognostic risk factor, it may be then be possible to more specifically focus ICD therapy to those who are most likely to benefit and avoid unnecessary device implantations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with LV ejection fraction (LVEF) ≤35% of ischemic or nonischemic etiology (as measured by a clinical echocardiogram, ventriculogram, or radionuclide study) referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
Key inclusion criteria (3 listed)
- LVEF≤35%, referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
- Between the ages of 21 and 80 years old
- Permission of the patient's clinical attending physician
Key exclusion criteria (8 listed)
- Patients who refuse or are unable to give consent.
- Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles)
- Minors.
- Pregnant women.
- NYHA Class IV heart failure.
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
Composite SCD outcomes
Time frame: Every 6 months for 5 years
The first occurrence of an adjudicated appropriate ICD firing for ventricular tachycardia/ventricular fibrillation or cardiac death not treated by the ICD.
1 secondary outcome
Composite cardiac outcomes
Time frame: Every 6 months for 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 17389270Schmidt A, Azevedo CF, Cheng A, Gupta SN, Bluemke DA, Foo TK, Gerstenblith G, Weiss RG, Marban E, Tomaselli GF, Lima JA, Wu KC. Infarct tissue heterogeneity by magnetic resonance imaging identifies enhanced cardiac arrhythmia susceptibility in patients with left ventricular dysfunction. Circulation. 2007 Apr 17;115(15):2006-14. doi: 10.1161/CIRCULATIONAHA.106.653568. Epub 2007 Mar 26.
- Results publication: PubMed 17911537Fernandes VR, Wu KC, Rosen BD, Schmidt A, Lardo AC, Osman N, Halperin HR, Tomaselli G, Berger R, Bluemke DA, Marban E, Lima JA. Enhanced infarct border zone function and altered mechanical activation predict inducibility of monomorphic ventricular tachycardia in patients with ischemic cardiomyopathy. Radiology. 2007 Dec;245(3):712-9. doi: 10.1148/radiol.2452061615. Epub 2007 Oct 2.
- Results publication: PubMed 18565399Wu KC, Weiss RG, Thiemann DR, Kitagawa K, Schmidt A, Dalal D, Lai S, Bluemke DA, Gerstenblith G, Marban E, Tomaselli GF, Lima JA. Late gadolinium enhancement by cardiovascular magnetic resonance heralds an adverse prognosis in nonischemic cardiomyopathy. J Am Coll Cardiol. 2008 Jun 24;51(25):2414-21. doi: 10.1016/j.jacc.2008.03.018.
- Results publication: PubMed 18566171Ouwerkerk R, Bottomley PA, Solaiyappan M, Spooner AE, Tomaselli GF, Wu KC, Weiss RG. Tissue sodium concentration in myocardial infarction in humans: a quantitative 23Na MR imaging study. Radiology. 2008 Jul;248(1):88-96. doi: 10.1148/radiol.2481071027.
- Results publication: PubMed 19322659Ardekani S, Weiss RG, Lardo AC, George RT, Lima JA, Wu KC, Miller MI, Winslow RL, Younes L. Computational method for identifying and quantifying shape features of human left ventricular remodeling. Ann Biomed Eng. 2009 Jun;37(6):1043-54. doi: 10.1007/s10439-009-9677-2. Epub 2009 Mar 26.
- Results publication: PubMed 19332463Bottomley PA, Wu KC, Gerstenblith G, Schulman SP, Steinberg A, Weiss RG. Reduced myocardial creatine kinase flux in human myocardial infarction: an in vivo phosphorus magnetic resonance spectroscopy study. Circulation. 2009 Apr 14;119(14):1918-24. doi: 10.1161/CIRCULATIONAHA.108.823187. Epub 2009 Mar 30.
- Results publication: PubMed 19808427Strauss DG, Selvester RH, Lima JA, Arheden H, Miller JM, Gerstenblith G, Marban E, Weiss RG, Tomaselli GF, Wagner GS, Wu KC. ECG quantification of myocardial scar in cardiomyopathy patients with or without conduction defects: correlation with cardiac magnetic resonance and arrhythmogenesis. Circ Arrhythm Electrophysiol. 2008 Dec;1(5):327-36. doi: 10.1161/CIRCEP.108.798660. Epub 2008 Dec 2.
- Results publication: PubMed 19185315Strauss DG, Wu KC. Imaging myocardial scar and arrhythmic risk prediction--a role for the electrocardiogram? J Electrocardiol. 2009 Mar-Apr;42(2):138.e1-8. doi: 10.1016/j.jelectrocard.2008.12.010. Epub 2009 Jan 30.
- Results publication: PubMed 27164184Arevalo HJ, Vadakkumpadan F, Guallar E, Jebb A, Malamas P, Wu KC, Trayanova NA. Arrhythmia risk stratification of patients after myocardial infarction using personalized heart models. Nat Commun. 2016 May 10;7:11437. doi: 10.1038/ncomms11437.
- Results publication: PubMed 27108939Zhang Y, Guallar E, Weiss RG, Stillabower M, Gerstenblith G, Tomaselli GF, Wu KC. Associations between scar characteristics by cardiac magnetic resonance and changes in left ventricular ejection fraction in primary prevention defibrillator recipients. Heart Rhythm. 2016 Aug;13(8):1661-6. doi: 10.1016/j.hrthm.2016.04.013. Epub 2016 Apr 19.
- Results publication: PubMed 22267750Wu KC, Gerstenblith G, Guallar E, Marine JE, Dalal D, Cheng A, Marban E, Lima JA, Tomaselli GF, Weiss RG. Combined cardiac magnetic resonance imaging and C-reactive protein levels identify a cohort at low risk for defibrillator firings and death. Circ Cardiovasc Imaging. 2012 Mar;5(2):178-86. doi: 10.1161/CIRCIMAGING.111.968024. Epub 2012 Jan 20.
- Results publication: PubMed 37640127Sani MM, Sung E, Engels M, Daimee UA, Trayanova N, Wu KC, Chrispin J. Association of epicardial and intramyocardial fat with ventricular arrhythmias. Heart Rhythm. 2023 Dec;20(12):1699-1705. doi: 10.1016/j.hrthm.2023.08.033. Epub 2023 Aug 26.
- Individual participant dataSharing planned: No
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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.
Katherine Wu, MD 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 Ischemic Cardiomyopathy and Nonischemic Cardiomyopathy, 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Wu, MD (410-502-7283, kwu@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite SCD outcomes (time frame: Every 6 months for 5 years). 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 NCT01076660, which also lists 24 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 20 Jan 2026.