Arrhythmic Risk Stratification in Nonischemic Dilated Cardiomyopathy

NCT04246450 | Unknown DMC FDA Device

• 1 other identifier: HIPPO-RECO
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Cardiac Death Due to Cardiac Arrhythmia; Dilated Cardiomyopathy

Keywords

Nonischemic dilated cardiomyopathy; Sudden cardiac death risk stratification; Tiered two-step approach; Noninvasive risk factors; Cardiac magnetic resonance imaging; Programmed ventricular stimulation

Outcome Measures

Primary Outcomes (1)

• Major arrhythmic event (MAE) occurrence (ICD activation ± sudden cardiac death ± sustained ventricular tachycardia/ventricular fibrillation)

  Sustained ventricular arrhythmias necessitating ICD therapy ± sudden cardiac death ± sustained ventricular tachycardia/ventricular fibrillation

  48 months (total follow up duration)

Secondary Outcomes (2)

• Mortality (all-cause and heart failure-related) - Heart failure-related hospitalization

  48 months (total follow up duration)

• Device-related complications

  48 months (total follow up duration)

Study Arms (6)

LVEF between 35%-50%, no noninvasive risk factors (NIRFs)

NO INTERVENTION

Follow up, no further intervention

LVEF between 35%-50%, NIRFs present, noninducible

NO INTERVENTION

Follow up, no further intervention

LVEF between 35%-50%, NIRFs present, inducible

ACTIVE COMPARATOR

All patients in this group will receive an ICD

Device: Implantable Cardioverter Defibrillator (ICD) insertion

LVEF <35%, no NIRFs present, noninducible

SHAM COMPARATOR

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

LVEF <35%, NIRFs present, noninducible

SHAM COMPARATOR

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

LVEF <35%, NIRFs present, inducible

SHAM COMPARATOR

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

Interventions

Implantable Cardioverter Defibrillator (ICD) insertion DEVICE

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.

LVEF <35%, NIRFs present, inducible; LVEF <35%, NIRFs present, noninducible; LVEF <35%, no NIRFs present, noninducible; LVEF between 35%-50%, NIRFs present, inducible

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ALL of the following criteria must be fulfilled:
• 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
• Patients will have to have been diagnosed \>6 months prior to enrolment in order to exclude reversible myocarditis cases
• Be on sinus rhythm or with paroxysmal atrial fibrillation to facilitate noninvasive risk factor (NIRF) presence assessment
• Age \>18 years and \<80 years
• On optimal medical therapy for at least 3 months

You may not qualify if:

• A patient will be excluded from the study if any of the following criteria are present:
• 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
• Permanent atrial fibrillation
• More than moderate left-sided valvular heart disease
• Epicardial vessel lumen stenoses \>70% detected on coronary angiogram36 in a major coronary artery
• Expected survival \<12months
• Pregnancy (planned and accidental)
• 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
• NYHA IV functional class
• Participation in another study with an active treatment arm
• Contraindication to either MRI performance or insertion of a transvenous ICD system

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Hippokrateion General Hospital of Athens

Athens, Attica, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Defibrillators, Implantable; Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants; Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Officials

• Konstantinos A Gatzoulis, MD

  Hippokrateion General Hospital of Athens

  STUDY CHAIR

Central Study Contacts

Konstantinos A Gatzoulis, MD

CONTACT

00306944580369; kgatzoul@med.uoa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Model Details: 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

Study Record Dates

• First Submitted: January 25, 2020
• First Posted: January 29, 2020
• Study Start: September 1, 2020
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)