Substrate and mechanisms of ventricular arrhythmia in non-ischemic cardiomyopathy

Recruiting

Conditions: dilated cardiomyopathy
heart muscle disease
10007521

Registration Number: NL-OMON38075

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 220

Inclusion Criteria

A) NICM patients with
- documented VA or
- suspected VA (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or
- high risk for VA (LVEF * 35% and NYHA functional class II or III*) or
- intermediate risk for VA (LVEF * 50%* and late enhancement on CE-MRI)
who are not admitted for cardiac surgery;B) NICM patients with
- documented VA or
- suspected VA (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or
- high risk for VA (LVEF * 35% and NYHA functional class II or III*)
who are admitted for cardiac surgery (e.g., mitral valve annuloplasty or CorCap)

C) Non-NICM patients (controls) who are admitted for
- Coronary artery bypass graft surgery and who do not have prior myocardial infarction.
- Aortic valve replacement.

Exclusion Criteria

Exclusion criteria are as follows:;- Age < 18 years or > 80 years
- Inadequate patient competence
- Pregnancy
- Inability to comply with the protocol due to haemodynamic instability
- Non-NICM (e.g., 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);Exclusion criteria for CE-MRI:
- According to the safety guidelines for MR-imaging. These can be found on Albinusnet: MRI / Veiligheidsrichtlijnen voor MR-imaging, http://albinusnet.lumc.nl/home/reg/pro/1010/60711030322284).;Exclusion criteria for blood sampling:
- Haemoglobin < 6.0 mmol/L

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are extent, location and pattern of fibrosis in<br /><br>biopsy specimens, in-vitro electrophysiological properties of biopsy specimens<br /><br>and electroanatomical mapping results. The main study endpoints are<br /><br>inducibility of VA, type of induced VA, spontaneous VA and type of spontaneous<br /><br>VA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters:<br /><br>- CE-MRI<br /><br>- 123-I MIBG/MIBI imaging<br /><br>- Collagen turnover markers<br /><br>- Electroanatomical mapping findings: low voltage, late potentials,<br /><br>fragmentation and progressive conduction delay during extrastimuli<br /><br>- Fibrosis (e.g. percentage of fibrotic cells and extracellular matrix) in<br /><br>biopsy specimens<br /><br><br /><br>Secondary study endpoints:<br /><br>- Heart failure<br /><br>- Cardiac mortality<br /><br>- All-cause mortality.<br /><br>- Disease progression (as assessed by 123-I MIBG/MIBI-scans and MRI-scans).</p><br>