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NCT03784586 Clinical Trial

Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients

Sudden Cardiac Death Clinical Trial

— ACADEMY 1  

Official title:
The Electrophysiological Study Guided ICD Strategy in Prevention of Arrhythmic Cardiac Death in Myotonic Dystrophy Type 1 Patients With Conduction System Disease (ACADEMY 1 Study)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03784586
Other study ID # 01_MD1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2012
Est. completion date May 31, 2023

Study information
Verified date June 2021
Source University of Campania "Luigi Vanvitelli"
Contact Vincenzo Russo, MD,PhD
Phone 0817064149
Email v.p.russo@libero.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to evaluate if the electrophysiological study (EPS) guided therapy, including the prophylactic implantation of implantable cardioverter defibrillator (ICD), in inducible patients, is able to improve survival in comparison with conventional therapy (CONV strategy) in Myotonic Dystrophy type 1 patients with conduction disorders.

Description:

Trial design: This is a double-arm prospective observational study. Patient population: To be included in the study, DM1 patients had to have at least 18 years old, LVEF >35% on two-dimensional echocardiography, permanent pacing indication after non-invasive electrocardiographic evaluation or invasive EPS evaluation, according to the current guidelines. The following exclusion criteria were applied: electrolyte imbalance, thyroid disorders, prior cardiac surgery, prior cardiac arrest, prior spontaneous sustained ventricular arrhythmias, absuntion of antiarrhythmic drugs or medication known to affect cardiac conduction. All eligible DM1 patients underwent EPS for programmed ventricular stimulation; those in whom a sustained ventricula arrhythmia was inducible underwent subsequently ICD implantation. Non-inducible DM1 patients did not receive an ICD and underwent pacemaker implantation. Endpoints: The primary endpoint was all-cause mortality. Secondary end-points were sudden death (SD), death due to cardiac arrhythmias, ICD interventions and arrhythmic events in implanted patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date May 31, 2023
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - MD1 diagnosis genetically confirmed - LVEF >35% on two-dimensional echocardiography - Permanent pacing indication according to the current guidelines Exclusion Criteria: - Electrolyte imbalance - Thyroid disorders - Prior cardiac surgery - Prior cardiac arrest - Prior spontaneous sustained ventricular arrhythmias

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Vincenzo Russo Naples

Sponsors (1)
Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sudden Cardiac Death 24 months
Secondary All-cause mortality 24 months
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