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Cardiomyopathy, DilatedNCT01940081

The Leiden Nonischemic Cardiomyopathy Study

An observational study of Cardiomyopathy, Dilated and Tachycardia, Ventricular, run by Leiden University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Transthoracic echocardiography, Exercise test and 24-hour Holter electrocardiogram
Type of treatment
Surgery or procedure
How many people
148 participants
Where
1 siteNetherlands
Study dates
Oct 2011to Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
  • 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)
  • Patients undergoing aortic valve replacement or coronary artery bypass graft surgery

Who cannot join

  • Age < 18 years or > 80 years
  • Inadequate patient competence
  • Pregnancy
  • Inability to comply with the protocol due to haemodynamic instability
  • 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)
  • Nonischemic cardiomyopathy
  • Prior myocardial infarction

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Dept. of Cardiology, Leiden University Medical Center

    Leiden

Other trials in Netherlands

About this 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.

Read more

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.

Being tested
Transthoracic echocardiography, Exercise test, 24-hour Holter electrocardiogram, Contrast-enhanced magnetic resonance imaging, 123-iodine metaiodobenzylguanidine imaging
Keywords
Cardiomyopathy, Dilated, Tachycardia, Ventricular, Ventricular Fibrillation, Arrhythmias, Cardiac/etiology, Arrhythmias, Cardiac/physiopathology, Magnetic Resonance Imaging, 3-Iodobenzylguanidine/diagnostic use, Sympathetic Nervous System/radionuclide imaging, Electrophysiologic Techniques, Cardiac, Biopsy, Genetic Testing, Echocardiography, Electrocardiography, Ambulatory, Exercise Test
Medical subject headings
Cardiomyopathy, Dilated, Tachycardia, Ventricular, Ventricular Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transthoracic echocardiographyOther

  • Exercise testOther

  • 24-hour Holter electrocardiogramOther

  • Contrast-enhanced magnetic resonance imagingOther

  • 123-iodine metaiodobenzylguanidine imagingOther

  • Blood samplesOther

  • Genetic analysisGenetic

  • Invasive electrophysiological studyProcedure or surgery

  • Endomyocardial biopsyProcedure or surgery

  • Intraoperative biopsyProcedure or surgery

  • Intraoperative mapping and/or ablationProcedure or surgery

Study groups in NCT01940081
Study groupRoleWhat they receive
Group A: Nonischemic cardiomyopathy - not admitted for surgeryPatients 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
Receives: 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 surgeryPatients 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)
Receives: 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: ControlsPatients without nonischemic cardiomyopathy (controls) who are admitted for: * Coronary artery bypass graft surgery and who do not have prior myocardial infarction * Aortic valve replacement
Receives: Other: Transthoracic echocardiography; Other: Exercise test; Other: 24-hour Holter electrocardiogram; Other: Contrast-enhanced magnetic resonance imaging; Other: Blood samples; Procedure: Intraoperative biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inducibility of ventricular arrhythmias

    Measured: Baseline electrophysiological study

  2. Type of induced ventricular arrhythmias

    Measured: Baseline electrophysiological study

  3. Spontaneous ventricular arrhythmias

    Measured: Up to 10 years

  4. Type of spontaneous ventricular arrhythmias

    Measured: Up to 10 years

Secondary outcomes (4)

  1. Hospital admissions for heart failure

    Measured: Up to 10 years

  2. Cardiac mortality

    Measured: Up to 10 years

  3. All-cause mortality

    Measured: Up to 10 years

  4. LV function/dimensions/compact fibrosis deterioration as assessed by 123-I MIBG imaging and/or CE-MRI

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2013 (estimated)
  2. Study startOct 2011
  3. Primary completionSep 2019
  4. Study completionSep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940081
Sponsor's protocol ID
Cardiomyopathy study
Status last verified
Feb 2020
First submitted
29 Aug 2013
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Piers SR, Androulakis AF, Yim KS, van Rein N, Venlet J, Kapel GF, Siebelink HM, Lamb HJ, Cannegieter SC, Man SC, Zeppenfeld K. Nonsustained Ventricular Tachycardia Is Independently Associated With Sustained Ventricular Arrhythmias in Nonischemic Dilated Cardiomyopathy. Circ Arrhythm Electrophysiol. 2022 Feb;15(2):e009979. doi: 10.1161/CIRCEP.121.009979. Epub 2022 Jan 28.

    PubMed 35089806

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiomyopathy, Dilated and Tachycardia, Ventricular, run by Leiden University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inducibility of ventricular arrhythmias (time frame: Baseline electrophysiological study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01940081, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.

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