Substrate and mechanisms of ventricular arrhythmia in non-ischemic cardiomyopathy

Substrate and mechanisms of ventricular arrhythmia in non-ischemic cardiomyopathy - Non-ischemic cardiomyopathy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38075

Enrollment

220

Registered

2011-10-19

Start date

2011-12-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dilated cardiomyopathy heart muscle disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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: Exclusion criteria are as follows:;- Age 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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results