The Leiden Nonischemic Cardiomyopathy Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Leiden University Medical Center
Sponsor:
Information provided by (Responsible Party):
Katja Zeppenfeld, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01940081
First received: August 29, 2013
Last updated: September 7, 2013
Last verified: September 2013

August 29, 2013
September 7, 2013
October 2011
October 2021   (final data collection date for primary outcome measure)
  • Inducibility of ventricular arrhythmias [ Time Frame: Baseline electrophysiological study ] [ Designated as safety issue: No ]
  • Type of induced ventricular arrhythmias [ Time Frame: Baseline electrophysiological study ] [ Designated as safety issue: No ]
  • Spontaneous ventricular arrhythmias [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Type of spontaneous ventricular arrhythmias [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01940081 on ClinicalTrials.gov Archive Site
  • Hospital admissions for heart failure [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Cardiac mortality [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • LV function/dimensions/compact fibrosis deterioration as assessed by 123-I MIBG imaging and/or CE-MRI [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Leiden Nonischemic Cardiomyopathy Study
The Leiden Nonischemic Cardiomyopathy Study

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.

Objectives: 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. 3) to evaluate disease progression in NICM.

Hypothesis: Improved understanding of the substrate and mechanisms of VA in NICM may allow more effective, individualized and substrate-based therapies to be developed.

Study design: A prospective cohort study.

Study population: 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).

Evaluation: All patients will be evaluated according to current standards for patients with NICM. Evaluation will include 24h-Holter, echocardiography, coronary angiogram and contrast-enhanced MRI (CE-MRI). If CE-MRI is performed in another hospital, additional recordings will be performed in our hospital. Additionally, blood samples (arterial, cardiac venous and peripheral venous) for collagen turnover markers will be taken from all patients. 123-iodine metaiodobenzylguanidine (123-I MIBG) 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.

Intervention: 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 on imaging and in biopsy specimens. The main study endpoints are inducibility of VA, type of induced VA, spontaneous VA and type of spontaneous VA.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Per patient:

Blood samples (40 mL) Ventricular biopsies

Probability Sample

Patients with nonischemic cardiomyopathy and controls who are admitted to the hospital

  • Cardiomyopathy, Dilated
  • Tachycardia, Ventricular
  • Ventricular Fibrillation
  • Other: Transthoracic echocardiography
  • Other: Exercise test
  • Other: 24-hour Holter electrocardiogram
  • Other: Contrast-enhanced magnetic resonance imaging
  • Other: 123-iodine metaiodobenzylguanidine imaging
  • Other: Blood samples
  • Genetic: Genetic analysis
  • Procedure: Invasive electrophysiological study
  • Procedure: Endomyocardial biopsy
  • Procedure: Intraoperative biopsy
  • Procedure: Intraoperative mapping and/or ablation
  • Group A: Nonischemic cardiomyopathy - not admitted for surgery

    Patients with nonischemic cardiomyopathy with:

    • documented ventricular arrhythmia or
    • suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or
    • high risk for ventricular arrhythmia (LVEF ≤ 35%) or
    • intermediate risk for ventricular arrhythmia (LVEF ≤ 50% and late enhancement on contrast-enhanced MRI)

    who are not admitted for cardiac surgery

    Interventions:
    • Other: Transthoracic echocardiography
    • Other: Exercise test
    • Other: 24-hour Holter electrocardiogram
    • Other: Contrast-enhanced magnetic resonance imaging
    • Other: 123-iodine metaiodobenzylguanidine imaging
    • Other: Blood samples
    • Genetic: Genetic analysis
    • Procedure: Invasive electrophysiological study
    • Procedure: Endomyocardial biopsy
  • Group B: Nonischemic cardiomyopathy -admitted for surgery

    Patients with nonischemic cardiomyopathy with:

    • documented ventricular arrhythmia or
    • suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or
    • high risk for ventricular arrhythmia (LVEF ≤ 35%)

    who are admitted for cardiac surgery (e.g., mitral valve annuloplasty or CorCap)

    Interventions:
    • Other: Transthoracic echocardiography
    • Other: Exercise test
    • Other: 24-hour Holter electrocardiogram
    • Other: Contrast-enhanced magnetic resonance imaging
    • Other: 123-iodine metaiodobenzylguanidine imaging
    • Other: Blood samples
    • Genetic: Genetic analysis
    • Procedure: Invasive electrophysiological study
    • Procedure: Intraoperative biopsy
    • Procedure: Intraoperative mapping and/or ablation
  • Group C: Controls

    Patients without nonischemic cardiomyopathy (controls) who are admitted for:

    • Coronary artery bypass graft surgery and who do not have prior myocardial infarction
    • Aortic valve replacement
    Interventions:
    • Other: Transthoracic echocardiography
    • Other: Exercise test
    • Other: 24-hour Holter electrocardiogram
    • Other: Contrast-enhanced magnetic resonance imaging
    • Other: Blood samples
    • Procedure: Intraoperative biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
October 2021
October 2021   (final data collection date for primary outcome measure)

Inclusion criteria, group A:

  • Nonischemic cardiomyopathy
  • Documented ventricular arrhythmia, suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or high risk for ventricular arrhythmias (LVEF ≤ 35%) or intermediate risk for ventricular arrhythmias (LVEF ≤ 50% and late enhancement on contrast-enhanced MRI)
  • Admission not for cardiac surgery

Inclusion criteria, group B:

  • Nonischemic cardiomyopathy
  • Documented ventricular arrhythmia or suspected ventricular arrhythmia (e.g. because of out-of-hospital cardiac arrest, palpitations or syncope) or high risk for ventricular arrhythmia (LVEF ≤ 35%)
  • Admission for cardiac surgery (e.g., mitral valve annuloplasty or CorCap)

Inclusion criteria, group C:

- Patients undergoing aortic valve replacement or coronary artery bypass graft surgery

Exclusion criteria, all groups:

  • Age < 18 years or > 80 years
  • Inadequate patient competence
  • Pregnancy
  • Inability to comply with the protocol due to haemodynamic instability

Exclusion Criteria, groups A and B:

- Other cardiomyopathy (e.g., prior myocardial infarction, infiltrative cardiac disease such as sarcoidosis, amyloidosis or Chagas cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, hypertrophic cardiomyopathy, non-compaction cardiomyopathy and congenital heart disease)

Exclusion criteria, group C:

  • Nonischemic cardiomyopathy
  • Prior myocardial infarction
Both
18 Years to 80 Years
No
Netherlands
 
NCT01940081
Cardiomyopathy study
No
Katja Zeppenfeld, Leiden University Medical Center
Leiden University Medical Center
Not Provided
Not Provided
Leiden University Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP