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Arrhythmic Risk Stratification in Nonischemic Dilated Cardiomyopathy (ReCONSIDER)

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ClinicalTrials.gov Identifier: NCT04246450
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Kostantinos A. Gatzoulis, University of Athens

Brief Summary:

Nonischemic dilated cardiomyopathy is a heterogeneous disease often associated with increased rates of sudden cardiac death. Although many algorithms have been proposed, risk stratification remains suboptimal, and implantable cardioverter-defibrillators are currently recommended only in patients with poor left ventricular function. However, most cases of sudden cardiac death occur at earlier stages, in patients with relatively preserved left ventricular function and exercise capacity, for which device-therapy is currently not indicated. Several noninvasive risk factors have been associated with increased arrhythmic risk, including clinical history (syncope), imaging (fibrosis on cardiac magnetic resonance imaging and left ventricular dimensions in echocardiography) and electrocardiographic parameters (ventricular arrhythmic burden, late potentials, heart rate variability and repolarization abnormalities).

The investigators hypothesized that the encouraging findings of studies assessing more sophisticated stratification-algorithms in patients with ischemic heart disease could be extrapolated in patients with nonischemic dilated cardiomyopathy. Thus, combining noninvasive risk factors with programmed ventricular stimulation may risk-stratify such patients more accurately. In this regard, the prospective observational multicenter ReCONSIDER study aims to integrate several approaches to arrhythmic risk stratification in nonischemic dilated cardiomyopathy in a tiered, multifactorial, approach, in which noninvasive risk factors are combined with electrophysiologic studies. This approach may pave the way for a more comprehensive risk stratification algorithm in patients with nonischemic dilated cardiomyopathy, leading to more rational device-therapy, and, ultimately to lower mortality.


Condition or disease Intervention/treatment Phase
Sudden Cardiac Death Due to Cardiac Arrhythmia Dilated Cardiomyopathy Device: Implantable Cardioverter Defibrillator (ICD) insertion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 675 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Based on the presence of noninvasive risk factors patients will be submitted to invasive programmed ventricular stimulation and receive an ICD if ventricular tachycardia / fibrillation (VT/Vf) are inducible
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Arrhythmic Risk Stratification in Nonischemic Dilated Cardiomyopathy: The ReCONSIDER Study. A Two-step, Multifactorial, Electrophysiology-inclusive Approach
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2025


Arm Intervention/treatment
No Intervention: LVEF between 35%-50%, no noninvasive risk factors (NIRFs)
Follow up, no further intervention
No Intervention: LVEF between 35%-50%, NIRFs present, noninducible
Follow up, no further intervention
Active Comparator: LVEF between 35%-50%, NIRFs present, inducible
All patients in this group will receive an ICD
Device: Implantable Cardioverter Defibrillator (ICD) insertion
Implantation of ICD when arrhythmic risk is deemed high in those with LVEF between 35%-50%, and to all with LVEF<35%. Aim to determine whether risk stratification accuracy can be improved more than that of the current approach regarding primary prevention of sudden cardiac arrhythmic death in nonischemic dilated cardiomyopathy patients (no ICDs to those with LVEF between 35%-50% and ICDs to all with LVEF <35%. In patients in the LVEF <35% groups, ICDs will be used as implantable recorders, to determine whether occurrence of major arrhythmic events (MAEs) can be better predicted by NIRFs/PVS than by LVEF alone.

Sham Comparator: LVEF <35%, no NIRFs present, noninducible
All patients in this group will receive an ICD, the aim is to compare major arrhythmic event occurrence according to NIRF presence and/or inducibility, and whether risk stratification accuracy can be improved as compared to classic approach of ICDs being offered to all dilated cardiomyopathy patients with LVEF<35%
Device: Implantable Cardioverter Defibrillator (ICD) insertion
Implantation of ICD when arrhythmic risk is deemed high in those with LVEF between 35%-50%, and to all with LVEF<35%. Aim to determine whether risk stratification accuracy can be improved more than that of the current approach regarding primary prevention of sudden cardiac arrhythmic death in nonischemic dilated cardiomyopathy patients (no ICDs to those with LVEF between 35%-50% and ICDs to all with LVEF <35%. In patients in the LVEF <35% groups, ICDs will be used as implantable recorders, to determine whether occurrence of major arrhythmic events (MAEs) can be better predicted by NIRFs/PVS than by LVEF alone.

Sham Comparator: LVEF <35%, NIRFs present, noninducible
All patients in this group will receive an ICD, the aim is to compare major arrhythmic event occurrence according to NIRF presence and/or inducibility, and whether risk stratification accuracy can be improved as compared to classic approach of ICDs being offered to all dilated cardiomyopathy patients with LVEF<35%
Device: Implantable Cardioverter Defibrillator (ICD) insertion
Implantation of ICD when arrhythmic risk is deemed high in those with LVEF between 35%-50%, and to all with LVEF<35%. Aim to determine whether risk stratification accuracy can be improved more than that of the current approach regarding primary prevention of sudden cardiac arrhythmic death in nonischemic dilated cardiomyopathy patients (no ICDs to those with LVEF between 35%-50% and ICDs to all with LVEF <35%. In patients in the LVEF <35% groups, ICDs will be used as implantable recorders, to determine whether occurrence of major arrhythmic events (MAEs) can be better predicted by NIRFs/PVS than by LVEF alone.

Sham Comparator: LVEF <35%, NIRFs present, inducible
All patients in this group will receive an ICD, the aim is to compare major arrhythmic event occurrence according to NIRF presence and/or inducibility, and whether risk stratification accuracy can be improved as compared to classic approach of ICDs being offered to all dilated cardiomyopathy patients with LVEF<35%
Device: Implantable Cardioverter Defibrillator (ICD) insertion
Implantation of ICD when arrhythmic risk is deemed high in those with LVEF between 35%-50%, and to all with LVEF<35%. Aim to determine whether risk stratification accuracy can be improved more than that of the current approach regarding primary prevention of sudden cardiac arrhythmic death in nonischemic dilated cardiomyopathy patients (no ICDs to those with LVEF between 35%-50% and ICDs to all with LVEF <35%. In patients in the LVEF <35% groups, ICDs will be used as implantable recorders, to determine whether occurrence of major arrhythmic events (MAEs) can be better predicted by NIRFs/PVS than by LVEF alone.




Primary Outcome Measures :
  1. Major arrhythmic event (MAE) occurrence (ICD activation ± sudden cardiac death ± sustained ventricular tachycardia/ventricular fibrillation) [ Time Frame: 48 months (total follow up duration) ]
    Sustained ventricular arrhythmias necessitating ICD therapy ± sudden cardiac death ± sustained ventricular tachycardia/ventricular fibrillation


Secondary Outcome Measures :
  1. Mortality (all-cause and heart failure-related) - Heart failure-related hospitalization [ Time Frame: 48 months (total follow up duration) ]
    All cause mortality, mortality due to heart failure, determined by death certificates

  2. Device-related complications [ Time Frame: 48 months (total follow up duration) ]
    Infections - pocket and lead related, as well as inappropriate therapies. Determined by reports of implanting physicians.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ALL of the following criteria must be fulfilled:

  1. Dilated cardiomyopathy diagnosis based on the ESC proposed criteria1: Dilation based on left ventricular end-diastolic diameter or volume >2SD larger than age, gender, and body surface area adjusted normal values, hypokinesia based on left ventricular ejection fraction ≤50%, not attributable to loading conditions or coronary artery disease. In cases of LVEF<45%, otherwise unexplained, and no evident ventricular dilation, the diagnosis of hypokinetic, nondilated CMP will be made
  2. Patients will have to have been diagnosed >6 months prior to enrolment in order to exclude reversible myocarditis cases
  3. Be on sinus rhythm or with paroxysmal atrial fibrillation to facilitate noninvasive risk factor (NIRF) presence assessment
  4. Age >18 years and <80 years
  5. On optimal medical therapy for at least 3 months

Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are present:

  1. Significant ventricular extrasystole burden (>10,000/24hrs or >10% PVCs) on 24hr ambulatory ECG (PVC-induced cardiomyopathy)38, 39, persisting even after all pharmacologic and/or interventional (ablation) attempts
  2. Permanent atrial fibrillation
  3. More than moderate left-sided valvular heart disease
  4. Epicardial vessel lumen stenoses >70% detected on coronary angiogram36 in a major coronary artery
  5. Expected survival <12months
  6. Pregnancy (planned and accidental)
  7. Stage IIIb chronic kidney disease (estimated glomerular filtration rate <30ml/hr). This mainly relates to the non-tachycardic SCD mechanisms in this population (bradycardia/pulseless electrical activity)40-42, not amenable to antitachycardic ICD interventions
  8. NYHA IV functional class
  9. Participation in another study with an active treatment arm
  10. Contraindication to either MRI performance or insertion of a transvenous ICD system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246450


Contacts
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Contact: Konstantinos A Gatzoulis, MD 00306944580369 kgatzoul@med.uoa.gr

Locations
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Greece
Hippokrateion General Hospital of Athens Recruiting
Athens, Attica, Greece, 11527
Contact: Konstantinos A Gatzoulis, MD    00306944580369    kgatzoul@med.uoa.gr   
Principal Investigator: Polychronis Dilaveris, MD         
Principal Investigator: Petros Arsenos, MD         
Principal Investigator: Dimitrios Tsiachris, MD         
Principal Investigator: Christos-Konstantinos Antoniou, MD         
Sub-Investigator: Skevos Sideris, MD         
Sub-Investigator: Panagiota Flevari, MD         
Sub-Investigator: Konstantinos Kappos, MD         
Sub-Investigator: Themistoklis Maounis, MD         
Sub-Investigator: Theofilos Kolettis, MD         
Sub-Investigator: Emmanuel Kanoupakis, MD         
Sub-Investigator: Antonios Sideris, MD         
Sub-Investigator: Aris Anastasakis, MD         
Sub-Investigator: Georgios Efhtimiadis, MD         
Sub-Investigator: Apostolos Katsivas, MD         
Sub-Investigator: Athanasios Kotsakis, MD         
Sub-Investigator: Vassilios Vassilikos, MD         
Sub-Investigator: Nikolaos Fragakis, MD         
Sub-Investigator: Charalambos Karvounis, MD         
Sub-Investigator: Emmanouil Simantirakis, MD         
Sub-Investigator: Panagiotis Korantzopoulos, MD         
Sub-Investigator: Charalampos Kossyvakis, MD         
Sub-Investigator: George Hahalis, MD         
Sub-Investigator: Georgios Leventopoulos, MD         
Principal Investigator: Konstantinos A Gatzoulis, MD         
Sub-Investigator: Athanasios Kordalis, MD         
Sub-Investigator: Michael Efremidis, MD         
Sub-Investigator: Anna Kostopoulou, MD         
Sub-Investigator: Ioannis Skiadas, MD         
Sub-Investigator: Panagiotis Margos, MD         
Sub-Investigator: Stylianos Paraskevaidis, MD         
Sub-Investigator: Konstantinos Paravolidakis, MD         
Sub-Investigator: Dimitrios Klettas, MD         
Sub-Investigator: Sophie Mavrogeni, MD         
Sub-Investigator: Efstathios Iliodromitis, MD         
Sub-Investigator: Dionysios Kalpakos, MD         
Sub-Investigator: Kyriakos Lazaridis, MD         
Sub-Investigator: Vlasios Pyrgakis, MD         
Sub-Investigator: Aristides Androulakis, MD         
Principal Investigator: Charalambos Vlachopoulos, MD         
Principal Investigator: Dimitrios Tousoulis, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Study Chair: Konstantinos A Gatzoulis, MD Hippokrateion General Hospital of Athens
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Responsible Party: Kostantinos A. Gatzoulis, Associate Professor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT04246450    
Other Study ID Numbers: HIPPO-RECO
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kostantinos A. Gatzoulis, University of Athens:
Nonischemic dilated cardiomyopathy
Sudden cardiac death risk stratification
Tiered two-step approach
Noninvasive risk factors
Cardiac magnetic resonance imaging
Programmed ventricular stimulation
Additional relevant MeSH terms:
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Cardiomyopathies
Arrhythmias, Cardiac
Cardiomyopathy, Dilated
Death, Sudden, Cardiac
Death
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiomegaly
Laminopathies
Genetic Diseases, Inborn
Heart Arrest
Death, Sudden