Electrophysiologic and Morphologic Assessment of the Substrate to Guide Implantation of Defibrillators in Dilated Cardiomyopathy

Status unconfirmed

Conditions studied: Dilated Cardiomyopathy, Primary Prevention of Sudden Cardiac Death, Implantable Cardioverter Defibrillator

In brief

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.

Key facts

Study ID

NCT01378572

Run by

Catholic University of the Sacred Heart

People needed

200

Starts

2009-11-01

Last updated by the study team

2011-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• Centro Cardiologico Monzino — Milan, Italy (enrolling)
• Policlinico "A. Gemelli" — Rome, Italy (enrolling)
• Texas Cardiac Arrhythmia Institute, St. David's Medical Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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