|- candidate number||11164|
|- NTR Number||NTR3319|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-feb-2012|
|- Secondary IDs||NL37472.058.11 CCMO|
|- Public Title||Het mechanisme van hartritmestoornissen
bij patiŽnten met een hartspierziekte.|
|- Scientific Title||Substrate and mechanisms of ventricular arrhythmia in nonischemic cardiomyopathy.|
|- hypothesis||Improved understanding of the substrate and mechanisms of VA in NICM may allow more effective, individualized and substrate-based therapies to be developed.|
|- Healt Condition(s) or Problem(s) studied||Nonischemic cardiomyopathy|
|- Inclusion criteria||1. Patients with nonischemic cardiomyopathy and documented/suspected ventricular arrhythmia or an intermediate to high risk for ventricular arrhythmia;|
2. Patients without nonischemic cardiomyopathy (controls) who are admitted for:
A. Coronary artery bypass graft surgery and who do not have prior myocardial infarction;
B. Aortic valve replacement.
|- Exclusion criteria||1. Age < 18 yrs or > 80 yrs;|
2. Inadequate patient competence;
4. Inability to comply with the protocol due to haemodynamic instability;
5. For nonischemic cardiomyopathy patients: prior myocardial infarction, infiltrative cardiac disease such as sarciodosis, amyloidosis or Chagas cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, hypertrophic cardiomyopathy, non-compaction cardiomyopathy and congenital heart disease.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||31-okt-2011|
|- planned closingdate||1-sep-2014|
|- Target number of participants||220|
|- Interventions||1. Intra-operative ablation of ventricular tachycardia in a small subset of patients who are admitted for cardiac surgery and have inducible ventricular arrhythmia with a suspected epicardial exit site during electrophysiological study. There is no control group for this group;|
2. No intervention in the majority of patients.
|- Primary outcome||1. Inducibility of ventricular arrhythmias during electrophysiological study at baseline;|
2. Type of induced ventricular arrhythmia during electrophysiological study at baseline;
3. Spontaneous ventricular arrhythmias during long-term follow-up;
4. Type of spontaneous ventricular arrhythmia during long-term follow-up.
|- Secondary outcome||1. Heart failure;|
2. Cardiac mortality;
3. All-cause mortality.
|- Timepoints||1. Extensive baseline evaluation (coronary angiography if not already performed, exercise test, 24-hour electrocardiogram, echocardiography, blood samples, electrophysiological study, endomyocardial biopsy, contrast-enhanced MRI, 123-I MIBG imaging);|
2. Follow-up: Primary and secondary endpoints.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| S.R.D. Piers|
|- CONTACT for SCIENTIFIC QUERIES|| S.R.D. Piers|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||Rationale: |
Sudden cardiac death, mainly caused by ventricular arrhythmias (VA), is a major cause of morbidity and mortality in non-ischemic cardiomyopathy (NICM). Therapies that effectively prevent VA are lacking. Improved understanding of the substrate and mechanisms of VA in NICM may allow more effective, individualized and substrate-based therapies to be developed. In addition, risk stratification in NICM needs to be improved so that therapies can be allocated more efficiently.
1. To improve our understanding of the underlying pro-arrhythmic substrate and electrophysiologic mechanisms of VA in NICM, and to develop individualized treatment for VA based on the identified substrate;
2. To improve risk stratification for VA and sudden cardiac death in NICM based on substrate characteristics.
A prospective cohort study.
The study population will consist of three groups (A, B and C): NICM patients with documented VA, suspected VA or intermediate to high risk for VA (according to established criteria) who are not referred for cardiac surgery (group A), NICM patients with documented VA, suspected VA or a high risk for VA who are referred for cardiac surgery (group B) and a control group consisting of patients without NICM who are referred for cardiac surgery (group C).
All patients will be evaluated according to current standards for patients with NICM. Evaluation will include 24h-Holter, exercise test, echocardiography, coronary angiogram and contrast-enhanced MRI (CE-MRI). Additionally, blood samples (arterial, cardiac venous and peripheral venous) will be taken from all patients. Nuclear imaging, electrophysiologic study and endomyocardial biopsy will be performed in group A and B. Intra-operative biopsy will be performed in group B and C.
In group B, intra-operative mapping and cryo-ablation and postoperative electrophysiologic study will be performed in patients with subepicardial late enhancement on MRI or induced VA suspected for an subepicardial origin.
Main study parameters/endpoints:
The main study parameters are extent, location and pattern of fibrosis in biopsy specimens, in-vitro electrophysiological properties of biopsy specimens and electroanatomical mapping results. The main study endpoints are inducibility of VA, type of induced VA, spontaneous VA and type of spontaneous VA.
|- Main changes (audit trail)|
|- RECORD||20-feb-2012 - 10-mrt-2012|