Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients (ACADEMY 1)

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    70
  • sponsor
    University of Campania "Luigi Vanvitelli"
Updated on 10 February 2022
conventional therapy
conduction disorders
sudden cardiac death
implantable cardioverter defibrillator
myotonic dystrophy

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.

Details
Condition Myotonic Dystrophy 1, Sudden Cardiac Death
Clinical Study IdentifierNCT03784586
SponsorUniversity of Campania "Luigi Vanvitelli"
Last Modified on10 February 2022

Eligibility

Yes No Not Sure

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
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