Dilated CardiomyopathyEMOSIDDNCT01378572
Electrophysiologic and Morphologic Assessment of the Substrate to Guide Implantation of Defibrillators in Dilated Cardiomyopathy
An observational study of Dilated Cardiomyopathy and Primary Prevention of Sudden Cardiac Death, run by Catholic University of the Sacred Heart at 3 sites in 2 countries.
Trial summary
With the present study the investigators intend to identify the morphologic and electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy undergoing implantation of a defibrillator for the primary prevention of sudden cardiac death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2009to not given
- 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 dilated cardiomyopathy (NYHA II-III heart failure, left ventricular ejection fraction <=35%) undergoing prophylactic ICD implantation.
Who may be able to join
- Males and females ≥18 year-old with full capacity.
- A New York Heart Association (NYHA) class II or III chronic, stable congestive heart failure (CHF).
- A left ventricular ejection fraction (LVEF) of no more than 35 percent.
Who cannot join
- Age <18 years or diminished capacity.
- Patients with LVEF ≥ 35% or asymptomatic left ventricular dysfunction.
- Patients with NYHA class IV CHF.
- Patients with history of ventricular arrhythmias causing pre-syncope or syncope, cardiac arrest or a spontaneous episode of sustained ventricular tachycardia (VT) (≥30 seconds at rates of >100 bpm), unless these occurred within 48 hours of a myocardial infarction.
- Females who are pregnant or have childbearing potential and are not using reliable methods of contraception.
- Patients with history of restrictive, infiltrative, or hypertrophic cardiomyopathy; arrhythmogenic cardiomyopathy; constrictive pericarditis; congenital heart disease; surgically correctable valvular disease; and/or inoperable obstructive valvular disease.
Show all 14Show fewer
- Patients with reversible nonischemic cardiomyopathy such as acute viral myocarditis, alcohol-induced cardiomyopathy, peripartum cardiomyopathy, Takotsubo cardiomyopathy.
- Patients with mechanical or biologic prosthetic cardiac valves.
- Patients with history of a major psychiatric disorder, active alcohol/drug abuse, or noncompliance.
- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 90 days prior to enrollment.
- Myocardial infarction within the past 90 days prior to enrollment.
- Angiographic evidence of coronary disease sufficient to be a candidate for coronary revascularization and likely to undergo coronary artery bypass graft surgery and/or percutaneous coronary intervention and likely to undergo such a procedure in the foreseeable future.
- Presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the study, including but not limited to cancer, uremia (blood urea nitrogen >70 mg/dl or creatinine >3.0 mg/dl), respiratory failure, hepatic failure, etc.
- Contraindication to cardiac magnetic resonance evaluation
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites, 2 recruiting
- Recruiting
Centro Cardiologico Monzino
Milan, 20138
Antonio Dello Russo, MD, +39 02 58002738, antonio.dellorusso@gmail.com
- Recruiting
Policlinico "A. Gemelli"
Rome, 00168
Gemma Pelargonio, MD, +390630154187, pelargonio@hotmail.com
United States1 site
- Active, not recruiting
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Austin, Texas, 78705
About this study
With the present study the investigators intend to identify the morphologic and electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy undergoing implantation of a defibrillator for the primary prevention of sudden cardiac death. Moreover, the investigators also aim to identify if there is any electrophysiological substrate modification at the time of the first arrhythmic event in these patients. To this aim, the investigators will prospectively correlate electroanatomic mapping and cardiac magnetic resonance findings with arrhythmic events, in order to identify substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy, who are therefore more likely to benefit from a defibrillator implantation. Furthermore, electroanatomic mapping will be repeated at the time of the first arrhythmic event and compared with that at baseline, in order to evaluate any electrophysiological substrate changes.
Read the detailed description
A correct identification of patients at high risk of sudden cardiac death is crucial for a rational clinical management, since the demonstrated effectiveness of implantable cardioverter-defibrillators on the reduction of sudden cardiac death. Basing on the results of multiple clinical trials, left ventricular systolic function, measured as ejection fraction, is currently the only recommended tool to identify patients at higher risk of sudden death that would benefit from a prophylactic defibrillator. However, the systematic implementation of current recommendations results in a substantial number of inappropriate defibrillator implantations, while failing to prevent the majority of sudden deaths occurring in the general population. Unfortunately, at present time we have no other way to identify patients at higher risk of sudden cardiac death, since other proposed risk markers have not been consistently demonstrated of incremental value. Recent data suggest that several substrate markers, either assessed morphologically with magnetic resonance imaging, or electrophysiologically with invasive mapping procedures, may be helpful to identify subgroup of patients at higher arrhythmic risk. However, previous studies have been largely conducted on few patients, most were retrospective or with short follow-up.
We will submit patients with dilated cardiomyopathy undergoing implant of an implantable cardioverter defibrillator to a morphologic and electrophysiologic substrate evaluation including cardiac magnetic resonance with gadolinium contrast-enhancement study, and electroanatomic mapping with bipolar electrogram voltage and morphological analysis. The electroanatomic mapping and cardiac magnetic resonance will be repeated at the time of the first arrhythmic event.
We expect to define the role of anatomical and electrophysiological substrate abnormalities in determining malignant ventricular arrhythmias in patients with dilated cardiomyopathy, thus allowing a better risk stratification and prevention of sudden death.
- Conditions
- Dilated Cardiomyopathy, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- Keywords
- ICD, sudden cardiac death, mapping
- Medical subject headings
- Cardiomyopathy, Dilated, Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmic Event
ICD shock on rapid sustained ventricular tachycardia or ventricular fibrillation or effective antitachycardia pacing.
Measured: 2 years
Change in Arrhythmogenic Substrate
Change in the arrhythmogenic substrate in patients who will experience an arrhythmic event compared to a matched control group who will remain free from arrhythmic event.
Measured: 2 years
Secondary outcomes (2)
Heart failure events
Hospitalization for heart failure events
Measured: 2 years
Death
All-cause mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Cardiac Arrhythmia Research Foundation, Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Milan, Italy, Policlinico Casilino ASL RMB, Rome, Italy, Dell'Angelo Hospital, Mestre-Venice, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378572
- Sponsor's protocol ID
- SDMC060911
- Acronym
- EMOSIDD
- Status last verified
- Jun 2011
- First submitted
- 21 Jun 2011
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiologic and Morphologic Assessment of the Substrate to Guide Implantation of Defibrillators in Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01378572
- Acronym / sponsor ID
- EMOSIDD / SDMC060911
- Conditions
- Dilated Cardiomyopathy, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator
- Keywords
- ICD, sudden cardiac death, mapping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Texas Cardiac Arrhythmia Research Foundation, Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Milan, Italy, Policlinico Casilino ASL RMB, Rome, Italy, Dell'Angelo Hospital, Mestre-Venice, Italy
- Study start
- Nov 2009
- First posted
- 22 Jun 2011 (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.
With the present study the investigators intend to identify the morphologic and electrophysiologic substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy undergoing implantation of a defibrillator for the primary prevention of sudden cardiac death. Moreover, the investigators also aim to identify if there is any electrophysiological substrate modification at the time of the first arrhythmic event in these patients. To this aim, the investigators will prospectively correlate electroanatomic mapping and cardiac magnetic resonance findings with arrhythmic events, in order to identify substrate markers of increased arrhythmic risk in patients with dilated cardiomyopathy, who are therefore more likely to benefit from a defibrillator implantation. Furthermore, electroanatomic mapping will be repeated at the time of the first arrhythmic event and compared with that at baseline, in order to evaluate any electrophysiological substrate changes.
Detailed description
A correct identification of patients at high risk of sudden cardiac death is crucial for a rational clinical management, since the demonstrated effectiveness of implantable cardioverter-defibrillators on the reduction of sudden cardiac death. Basing on the results of multiple clinical trials, left ventricular systolic function, measured as ejection fraction, is currently the only recommended tool to identify patients at higher risk of sudden death that would benefit from a prophylactic defibrillator. However, the systematic implementation of current recommendations results in a substantial number of inappropriate defibrillator implantations, while failing to prevent the majority of sudden deaths occurring in the general population. Unfortunately, at present time we have no other way to identify patients at higher risk of sudden cardiac death, since other proposed risk markers have not been consistently demonstrated of incremental value. Recent data suggest that several substrate markers, either assessed morphologically with magnetic resonance imaging, or electrophysiologically with invasive mapping procedures, may be helpful to identify subgroup of patients at higher arrhythmic risk. However, previous studies have been largely conducted on few patients, most were retrospective or with short follow-up.
We will submit patients with dilated cardiomyopathy undergoing implant of an implantable cardioverter defibrillator to a morphologic and electrophysiologic substrate evaluation including cardiac magnetic resonance with gadolinium contrast-enhancement study, and electroanatomic mapping with bipolar electrogram voltage and morphological analysis. The electroanatomic mapping and cardiac magnetic resonance will be repeated at the time of the first arrhythmic event.
We expect to define the role of anatomical and electrophysiological substrate abnormalities in determining malignant ventricular arrhythmias in patients with dilated cardiomyopathy, thus allowing a better risk stratification and prevention of sudden death.
Study design
- Observational model
- Case-control
- 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 dilated cardiomyopathy (NYHA II-III heart failure, left ventricular ejection fraction <=35%) undergoing prophylactic ICD implantation.
Key inclusion criteria (3 listed)
- Males and females ≥18 year-old with full capacity.
- A New York Heart Association (NYHA) class II or III chronic, stable congestive heart failure (CHF).
- A left ventricular ejection fraction (LVEF) of no more than 35 percent.
Key exclusion criteria (14 listed)
- Age <18 years or diminished capacity.
- Patients with LVEF ≥ 35% or asymptomatic left ventricular dysfunction.
- Patients with NYHA class IV CHF.
- Patients with history of ventricular arrhythmias causing pre-syncope or syncope, cardiac arrest or a spontaneous episode of sustained ventricular tachycardia (VT) (≥30 seconds at rates of >100 bpm), unless these occurred within 48 hours of a myocardial infarction.
- Females who are pregnant or have childbearing potential and are not using reliable methods of contraception.
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
Arrhythmic Event
Time frame: 2 years
ICD shock on rapid sustained ventricular tachycardia or ventricular fibrillation or effective antitachycardia pacing.
Change in Arrhythmogenic Substrate
Time frame: 2 years
Change in the arrhythmogenic substrate in patients who will experience an arrhythmic event compared to a matched control group who will remain free from arrhythmic event.
2 secondary outcomes
Heart failure events
Time frame: 2 years
Death
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathy and Primary Prevention of Sudden Cardiac Death, run by Catholic University of the Sacred Heart at 3 sites in 2 countries.
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 14 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: status not confirmed, as of the sponsor's last update on 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pasquale Santangeli, MD (5127014689, pasquale.santangeli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmic Event (time frame: 2 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?
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 22 Jun 2011.